Clinical Trials in China / NCT07577479
Active, not recruiting
Phase 1
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
NCT07577479 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Participants Study
Investigational drug(s) / intervention(s)
BW-50218 Injection →Saline (0.9% NaCl)
BW-50218 Injection: Solution for injection
Saline (0.9% NaCl): Solution for injection
Study summary
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
Eligibility
Inclusion Criteria:
* Capable of providing written informed consent and complying with all study procedures for the duration of the study.
* Body weight \> 50 kg for males and \> 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
* Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
* Male participants with partners of childbearing potential must agree to use effective contraception.
Exclusion Criteria:
* Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
* Recent hospitalization or a significant acute medical event.
* History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
* Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
* Positive test for hepatitis B, hepatitis C, or HIV.
Primary outcome measure(s)
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES) — From baseline up to Day 360 (End of Study)
Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007). - Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. - Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. - Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. - Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. - Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. - Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged. - Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group — From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed. - Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. — From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed. - Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. — From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed. - Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. — From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed. - Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized. — From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis). - Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized. — From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis). - Change from Baseline in Physical Examination Findings — From baseline up to Day 360 (End of Study)
Assessment of clinically significant changes in physical examination findings - Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group. — From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Argo Investigative Site | Shanghai | China |
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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 NCT07577479 on ClinicalTrials.gov ↗ ← All trials in China