Clinical Trials in China / NCT07918456
Enrolling by invitation
Phase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
NCT07918456 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Hepatitis B
Investigational drug(s) / intervention(s)
CPU-YL01 Injection Intramuscular administrationPlacebo intramuscular injection
CPU-YL01 Injection Intramuscular administration: Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Placebo intramuscular injection: Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 trial. It aims to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CPU-YL01 injection in chronic hepatitis B patients who have received nucleos(t)ide analog therapy. Single-dose and multiple-dose escalations will be conducted in this study
Eligibility
Inclusion Criteria:
1. Voluntarily sign the informed consent form (ICF), understand this study, and be willing and able to comply with and complete all trial procedures;
2. Open to all genders; age range: 18-70 years(inclusive);
3. The body mass index (BMI) ranges from 18 to 30 kg/m2(including the boundary values);
4. Clinically diagnosed chronic hepatitis B (serum HBsAg positivity for ≥6 months; outpatient medical records, inpatient medical records, or laboratory test results may serve as evidence);
5. During the screening phase, the HBsAg test result was ≤10,000 IU/mL (for participants in single-dose studies); or the HBsAg test result was ≤3,000 IU/mL (for participants in multiple-dose studies);
6. Patients currently receiving a stable dose of monotherapy or combination therapy with one or two nucleos(t)ide analogs for hepatitis B virus (HBV) treatment are required to have had no changes in their nucleos(t)ide analog regimen during the preceding 6 months, and no plans to alter their nucleos(t)ide analog regimen during the trial period. The eligible treatment options are limited to the following five agents: tenofovir alafenamide fumarate (TAF), teltenofovir mesylate (TMF), tenofovir disoproxil fumarate (TDF), prafenomide mesylate tablets (formerly known as paradenomide mesylate tablets; brand name: Xinshumu), or entecavir (ETV);
7. The HBV DNA test result during the screening phase was negative (below the lower detection limit of the local research center);
8. Male trial participants and female trial participants of childbearing age shall agree to use effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.
Exclusion Criteria:
1. A history of liver cirrhosis (confirmed by liver biopsy), or the presence of complications such as gastroesophageal variceal bleeding, hepatic encephalopathy, or ascites, or a liver stiffness measurement\>12.4 kPa during screening;
2. Presence of other clinically significant liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver disease, drug-induced hepatitis, α1-antitrypsin deficiency, Wilson's disease, etc.;
3. Use of immunosuppressants or immunomodulators (e.g., thymus) within 6 months prior to the first dose Patients taking peptides or cytotoxic agents, or those who have received corticosteroid therapy (excluding topical, inhalational, or ophthalmic treatments) for at least one week within 6 months prior to the first dose, or those who have had a history of vaccination within 1 month prior to screening or have planned to receive vaccinations during the trial period;
4. Prior to the first dose, the subject has received interferon or peginterferon therapy within the preceding 6 months, or plans to receive interferon or peginterferon therapy during the trial period;
5. Positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or positive for Treponema pallidum (TP) antibodies with confirmatory positive results on the rapid plasma reagin (RPR) test;
6. Exclusion criteria include a history of malignant tumor or recurrence within the 5 years prior to the first dose, except for specific cancers that can be cured by surgical resection (e.g., non-melanoma skin cancer, cervical intraepithelial neoplasia, thyroid tumors, breast tumors, etc., that have already been treated and show no signs of recurrence);
7. Has previously undergone organ transplantation;
8. Patients with a prior history of myocarditis, pericarditis, or idiopathic cardiomyopathy;
9. Participants who, at the time of screening, suffer from systemic severe diseases affecting other organs-including but not limited to the gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, or immunological systems (including but not limited to immunodeficiency or immunosuppression), as well as psychiatric or cardiovascular and cerebrovascular diseases-and who have been determined by the study physician to be unsuitable for participation in this trial;
10. Suffering from a progressive neurological disorder;
11. Patients with poorly controlled diabetes \[fasting plasma glucose\>7.0 mmol/L and/or HbA1c ≥7.5%\] or hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), for whom the investigator determines that they are unsuitable to participate in this trial;
12. Patients with a severe allergic constitution, a history of allergies to multiple foods or medications, or a known allergy to the test drug or its excipients;
13. Subjects who exhibit significant abnormalities in laboratory tests or electrocardiogram (ECG) findings during the screening phase, and whom the investigator determines to be unsuitable for participation in this trial, including but not limited to:
1. ALT or AST ≥ 2×ULN;
2. TBil ≥ 2×ULN and direct bilirubin (DBil)\> 1.5×ULN;
3. Albumin \<38 g/L;
4. Platelet count \<125×10\*9/L;
5. Absolute neutrophil count \<1.5×10\*9/L;
6. Prothrombin time (PT)\>3s, or international normalized ratio (INR)\>1.3;
7. Creatinine clearance (using the Cockcroft-Gault formula) \<60 mL/min;
8. Alpha-fetoprotein (AFP)\> 20 μg/L;
9. QTcF\> 450 ms (men) or\> 470 ms (women);
14. A history of drug use or alcohol abuse \[weekly alcohol consumption exceeding 14 alcohol units (1 alcohol unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits)\];
15. Having participated in other drug clinical trials and used trial drugs, or having participated in clinical trials of medical devices or vaccines, within 3 months prior to the first dose administration or within 5 drug half-life periods (whichever period is longer);
16. In this trial, participants who previously participated in the single-dose trial of CPU-YL01 may be re-screened for enrollment during the multiple-dose trial phase; the time limit requirements for prior trial participation of such participants shall be consistent with the exclusion criteria specified in Clause 15.
17. Women who are pregnant or breastfeeding;
18. The researchers believe that the subject is unsuitable to participate in this trial due to other reasons.
Primary outcome measure(s)
- adverse events [Safety and Tolerability Evaluation Endpoints] — For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events - serious adverse events [Safety and Tolerability Evaluation Endpoints] — For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
serious adverse events - adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events of particular concern (AESI) - vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints] — Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-Blood Pressure (mmHg) - vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints] — Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-respiratory rate (breaths/min) - vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints] — Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-body temperature (°C) - vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints] — Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-pulse rate (beats/min) - physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category. - physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category. - physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category. - physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category. - physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category. - physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category. - physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category. - physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category. - physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category. - physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category. - physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category. - physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.) - physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard). Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported. - physical examination-lymph nodes-assessment for lymph nodes mobility (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node mobility -mobile, fixed. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes - Assessment of lymph node mobility (mobile / fixed). Among participants with enlarged lymph nodes, lymph node mobility will be assessed (mobile, fixed). The number of participants in each mobility category will be reported. - physical examination-lymph nodes-assessment for tenderness (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node tenderness tender, non-tender. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes -assessment for tenderness. Among participants with enlarged lymph nodes, assessment for lymph node tenderness (tender, non-tender). The number of participants in each tenderness category will be reported. - physical examination-head-Face: assessment for dull facies-The number of participants with dull facies [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for dull facies. The number of participants with dull facies will be reported. - physical examination-head-Face: assessment for facial edema-The number of participants with facial edema [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for facial edema. The number of participants with facial edema will be reported. - physical examination-head-Eyes: assessment for eyelid edema-The number of participants with eyelid edema [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for eyelid edema. The number of participants with eyelid edema will be reported. - physical examination-head-Eyes: assessment for pupillary light reflex-The number of participants with normal, abnormal pupillary light reflex [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for pupillary light reflex. Assessment of pupillary light reflex (normal / abnormal). The number of participants with normal, abnormal pupillary light reflex will be reported. - physical examination-head-assessment for alopecia- The number of participants with alopecia [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-assessment for alopecia. The number of participants with alopecia will be reported. - physical examination-neck-assessment for Thyroid Enlargement- The number of participants with Thyroid Enlargement [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid Enlargement. The number of participants with Thyroid Enlargement will be reported. - physical examination-neck-assessment for Thyroid nodules-The number of participants with Thyroid nodules [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid nodules. The number of participants with Thyroid nodules will be reported. - physical examination-neck-assessment of tracheal position-The number of participants with tracheal position midline / deviated [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment of tracheal position (midline / deviated). The number of participants in each category will be reported. - physical examination-neck-assessment for nuchal rigidity-The number of participants with nuchal rigidity [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for nuchal rigidity. The number of participants with nuchal rigidity will be reported. - physical examination- chest-Lungs: assessment of breath sound clarity-The number of participants with lung breath sounds clear, wheezes, rales. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Lungs: Assessment of lung breath sounds (clear, wheezes, rales). The number of participants in each category will be reported. - physical examination- chest-Heart: assessment of cardiac rhythm regularity-The number of participants with cardiac rhythm regular, irregular. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: Assessment of cardiac rhythm (regular / irregular). The number of participants in each category will be reported. - physical examination- chest-Heart: assessment of cardiac murmur-The number of participants with cardiac murmur present, absent. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: Assessment for cardiac murmur (present / absent). The number of participants in each category will be reported. - physical examination-abdomen-Liver: assessment of Palpability of Liver Edge Below Right Midclavicular Costal Margin-The number of participants with the liver edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver. Abdominal palpation to assess whether the liver edge is palpable below the right midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported. - physical examination-abdomen-Liver: Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter)(For participants with a palpable liver edge)[Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver-Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter). For participants with a palpable liver edge below the right midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable liver edge. - physical examination-abdomen-Liver: assessment of hepatic consistency-The number of participants with hepatic consistency soft, firm, hard.(For participants with a palpable liver edge) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of consistency (soft, firm, hard). Among participants with a palpable liver edge below the costal margin, hepatic consistency is assessed (soft, firm, hard). The number of participants in each consistency category will be reported. - physical examination-abdomen-assessment for abdominal wall varices-The number of participants with abdominal wall varices [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal wall varices.The number of participants with abdominal wall varices will be reported. - physical examination-abdomen-assessment for abdominal tenderness-The number of participants with abdominal tenderness [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal tenderness.The number of participants with abdominal tenderness will be reported. - physical examination-abdomen-assessment for rebound tenderness-The number of participants with rebound tenderness. [Safety and Tolerability Evaluation Endpoints — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for rebound tenderness. The number of participants with rebound tenderness will be reported. - physical examination-abdomen-assessment for shifting dullness (indicative of ascites)-The number of participants-shifting dullness for ascites screening positive, negative. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Percussion assessment for shifting dullness for ascites screening (positive / negative). The number of participants in each category will be reported. - physical examination-abdomen-Spleen: assessment of Palpability of Spleen Edge Below Left Midclavicular Costal Margin-The number of participants with the splenic edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen-Abdominal palpation to assess whether the splenic edge is palpable below the left midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported. - physical examination-abdomen-Spleen: Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter)(For participants with a palpable splenic edge ) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen- Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter) .For participants with a palpable splenic edge below the left midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable splenic edge. - physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema-The number of participants with bilateral lower extremity edema [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema. The number of participants with bilateral lower extremity edema will be reported. - physical examination- spine/limbs-Extremities: assessment for joint erythema-The number of participants with joint erythema [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint erythema.The number of participants with joint erythema will be reported. - physical examination- spine/limbs-Extremities: assessment for joint warmth -The number of participants with joint warmth [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint warmth. The number of participants with joint warmth will be reported. - physical examination- spine/limbs-Extremities: assessment for joint tenderness -The number of participants with joint tenderness [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint tenderness. The number of participants with joint tenderness will be reported. - physical examination- spine/limbs-Extremities: assessment for joint swelling -The number of participants with joint swelling [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported. - physical examination- spine/limbs-Spine: assessment for deformity The number of participants with Spine deformity. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for deformity. The number of participants with Spine deformity. will be reported. - physical examination- spine/limbs-Extremities: Spine: assessment for tenderness -The number of participants withwith Spine tenderness [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported. - physical examination- spine/limbs-Spine: assessment for limited range of motion The number of participants with limited range of motion . [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for limited range of motion. The number of participants with limited range of motion of Spine will be reported. - physical examination--assessment of development- The number of participants with development good, fair, poor. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-assessment of development. General physical examination assessment of development (good, fair, poor).. The number of participants in each category will be reported. - physical examination--assessment of nutritional status- The number of participants with nutritional status good, fair, poor. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-assessment of nutritional status. Assessment of nutritional status (good, fair, poor). The number of participants in each category will be reported. - physical examination--assessment of mental status- The number of participants with mental status alert, drowsy, agitated, comatose. [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-other areas-Assessment of mental status (alert, drowsy, agitated, comatose). The number of participants in each category will be reported. - 12-lead electrocardiogram-heart rate [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-heart rate - 12-lead electrocardiogram-PR interval [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-PR interval - 12-lead electrocardiogram-RR interval [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-RR interval - 12-lead electrocardiogram-QRS [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QRS - 12-lead electrocardiogram-QT interval [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QT interval - 12-lead electrocardiogram-QTcF [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QTcF - 12-lead electrocardiogram-electrocardiographic diagnostic results [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-electrocardiographic diagnostic results - Clinical laboratory tests-hematology-red blood cell count (RBC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-red blood cell count (RBC) - Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB) - Clinical laboratory tests-hematology-white blood cell count (WBC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-white blood cell count (WBC) - Clinical laboratory tests-hematology-absolute neutrophil count (ANC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-absolute neutrophil count (ANC) - Clinical laboratory tests-hematology-platelet count (PLT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-platelet count (PLT) - Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO) - Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC) - Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC) - Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U) - Clinical laboratory tests-Urinalysis-Concentration of ketones (KET) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET) - Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT) - Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST) - Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT) - Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2,Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP) - Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE) - Clinical laboratory tests-Blood biochemistry-Concentration of albumin (ALB) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests- Blood biochemistry-Concentration of albumin (ALB) - Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP) - Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil) - Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil) - Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr) - Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA) - Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN) - Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC) - Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG) - Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C) - Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C) - Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU) - Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels - Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels - Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels - Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels - Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels - Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA) - Clinical laboratory tests-Coagulation profile-prothrombin time (PT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin time (PT) - Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB) - Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT) - Clinical laboratory tests-Coagulation profile-thrombin time (TT) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-thrombin time (TT) - Clinical laboratory tests--Concentration of troponinI [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Concentration of troponinI - Clinical laboratory tests--Concentration of C-reactive protein (CRP) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Concentration of C-reactive protein (CRP) - Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel-Concentration of immunoglobulin G (IgG) - Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA) - Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4 [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4 - Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) - Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3 [Safety and Tolerability Evaluation Endpoints] — Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3 - abdominal ultrasound- liver-Liver size(millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Liver size (millimeter) - abdominal ultrasound- liver-Hepatic Capsule - The number of participants with hepatic capsule findings normal, abnormal.[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Abdominal examination for hepatic capsule findings (normal / abnormal). The number of participants in each category will be reported. - abdominal ultrasound- liver-Hepatic Parenchymal echotexture - The number of participants with hepatic parenchymal echotexture normal, abnormal.[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Parenchymal echotexture. Assessment of hepatic parenchymal echotexture (normal / abnormal). The number of participants in each category will be reported. - abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter).[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter) - abdominal ultrasound- liver-intrahepatic biliary duct dilation-The number of participants with intrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-intrahepatic biliary duct dilation. The number of participants with intrahepatic biliary duct dilation will be reported. - abdominal ultrasound- liver-extrahepatic biliary duct dilation-The number of participants with extrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-extrahepatic biliary duct dilation.The number of participants with extrahepatic biliary duct dilation will be reported. - abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion-The number of participants with the presence or absence of hepatic solid space-occupying lesions .[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion. Abdominal ultrasound assessment for the presence or absence of hepatic solid space-occupying lesions. The number of participants in each category will be reported. Among participants with identified lesions, lesion size and location will be summarized. - abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter).( For participants with hepatic solid space-occupying lesions identified on abdominal ultrasound)[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter) . Among participants with hepatic solid space-occupying lesions identified on abdominal ultrasound, lesion size will be recorded in centimeters. Lesion location will also be documented. This field will be blank for participants without hepatic solid space-occupying lesions. - abdominal ultrasound-gallbladder-Gallbladder wall Thickness(millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-Gallbladder wall Thickness (millimeter) - abdominal ultrasound-gallbladder-gallstones-The number of participants with the presence or absence of gallstones[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallstones. Ultrasound assessment for the presence or absence of gallstones. The number of participants in each category will be reported. - abdominal ultrasound-gallbladder-gallbladder polyps-The number of participants with the presence or absence of gallbladder polyps. [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallbladder polyps. Ultrasound assessment for the presence or absence of gallbladder polyps. The number of participants in each category will be reported. - abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter).Ultrasound measurement of pancreatic duct internal diameter. Measurements will be recorded and reported in millimeters. - abdominal ultrasound-pancreas-Pancreatic Contour-The number of participants with pancreatic contour normal, abnormal. [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Contour. Ultrasound assessment of pancreatic contour (normal / abnormal). The number of participants in each category will be reported. - abdominal ultrasound-spleen-Spleen Longitudinal Diameter (millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- spleen-Spleen Longitudinal Diameter (millimeter). Ultrasound measurement of splenic longitudinal diameter. The measured value will be reported in millimeters. - abdominal ultrasound-spleen-Spleen Thickness (millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic thickness(millimeter). Ultrasound measurement of splenic thickness. The measured value will be reported in millimeters. - abdominal ultrasound-spleen-Splenic Vein Internal Diameter(millimeter)[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic Vein Internal Diameter (millimeter). Ultrasound measurement of splenic vein internal diameter. The measured value will be reported in millimeters. - abdominal ultrasound-Ascites Volume-The number of participants with Ascites none, mild, moderate, or large volume[Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-Ascites Volume-Ultrasound assessment for free intraperitoneal fluid (ascites). Ascites will be categorized as none, mild, moderate, or large volume. The number of participants in each category will be reported. - abdominal ultrasound-both kidneys-Renal cortical thickness(millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal cortical thickness (millimeter). Ultrasound measurement of renal cortical thickness. Measurements will be recorded and reported in millimeters. - abdominal ultrasound-both kidneys--Renal Pelvic Dilation Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal Pelvic Dilation Diameter (millimeter). Ultrasound measurement of renal pelvic dilation diameter. Measurements will be reported in millimeters. - abdominal ultrasound-both kidneys--renal cyst -The number of participants with the presence or absence of renal cysts. [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-presence or absence of renal cysts. Ultrasound assessment for the presence or absence of renal cysts. The number of participants in each category will be reported. Among participants with renal cysts, cyst size will be measured in millimeters and summarized - abdominal ultrasound-both kidneys-Size of Renal Cyst (millimeter). (For participants with identified renal cysts). [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Size of Renal Cyst (millimeter)For participants with identified renal cysts, cyst size will be recorded in millimeters. This field will be left blank for participants without renal cysts. - abdominal ultrasound-both kidneys-Renal Stone -The number of participants with the presence or absence of -Renal Stone. [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal Stone.Ultrasound assessment for the presence or absence of renal stones. The number of participants in each category will be reported. Among participants with renal stones, stone size will be measured in millimeters and summarized. - abdominal ultrasound-both kidneys-Size of Renal Stone (millimeter). (For participants with identified Renal Stone). [Safety and Tolerability Evaluation Endpoints] — For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Size of Renal Stone (millimeter).For participants with identified renal stones, stone size will be recorded in millimeters. This field will be left blank for participants without renal stones. - FibroScan-Liver stiffness value (LSM, unit: kPa)[Safety and Tolerability Evaluation Endpoints] — For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Liver stiffness value (LSM, unit: kPa): The specific liver stiffness number and its range, used to assess the degree of liver fibrosis. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients. - FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m) [Safety and Tolerability Evaluation Endpoints] — For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m). The specific CAP data and its range are used to assess the degree of liver fat changes. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients. - injection site monitoring-Pain-Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pain-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported. - injection site monitoring- Induration-Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring- Induration(2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported. - injection site monitoring-swelling-Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring--swelling (2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported. - injection site monitoring-Rash (erythema) -Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Rash (erythema) (2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported. - injection site monitoring-Pruritus (at the injection site)-Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pruritus (at the injection site)-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category will be reported. - injection site monitoring-Phlegmon -Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints] — Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Phlegmon -(Requires non-parenteral therapy (e.g., oral antibacterial, antifungal, antiviral treatment) OR requires other invasive procedures/Requires intravenous therapy (e.g., intravenous antibacterial, antifungal, antiviral treatment)/ Sepsis, or tissue necrosis, etc.). Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing You'an Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Beijing Jishuitan Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Henan Province Infectious Disease Hospital (Zhengzhou Sixth People's Hospital) | Zhengzhou | Henan | |
| Gulou Hospital, Nanjing University Medical School | Nanjing | Jiangsu |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07918456 on ClinicalTrials.gov ↗ ← All trials in China