Starting soon
Phase 2
A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
Condition(s) studied
Rabies (Healthy Volunteers)
Investigational drug(s) / intervention(s)
Recombinant Human Rabies Virus Monoclonal Antibody InjectionHuman Rabies Immunoglobulin (HRIG)PlaceboRabies Vaccine
Recombinant Human Rabies Virus Monoclonal Antibody Injection: On Day 0, administer via intramuscular injection into the lateral thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to co-administer at the same injection site.
Human Rabies Immunoglobulin (HRIG): On Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
Placebo: On Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
Rabies Vaccine: On Days 0, 3, 7, 14, and 28, administer via intramuscular injection into the deltoid muscle of the upper arm. Injection into the gluteal region is prohibited. The injection on Day 0 should be administered as soon as possible after the administration of the investigational product.
Study summary
A Phase II, Single-Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody Injection in Healthy Subjects
Eligibility
Inclusion Criteria:
1. Healthy individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification.
2. Participants voluntarily agree to participate in the study and sign an informed consent form.
3. Female participants must have no plans for pregnancy or egg donation from 14 days prior to dosing until 6 months after dosing and must voluntarily adopt effective physical contraceptive measures. Male participants must have no plans for pregnancy or sperm donation within 6 months after dosing and must voluntarily adopt effective physical contraceptive measures.
4. Female participants must weigh ≥45.0 kg and ≤80.0 kg, and male participants must weigh ≥50.0 kg and ≤80.0 kg. Body mass index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight in kg / height in m²).
5. Vital signs (reference ranges: systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-100 beats per minute, all inclusive; body temperature assessed by the investigator according to the research center's standards), physical examination, and clinical laboratory and auxiliary tests during the screening period must be normal or judged by the investigator to have no clinical significance if abnormal.
Exclusion Criteria:
1. Known allergy to the investigational product (including excipients or similar drugs), or individuals with a history of severe allergic diseases or considered allergic constitution (e.g., allergies to two or more drugs, foods, or pollen) as judged by the investigator to potentially compromise participant safety.
2. Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).
3. History of clinically severe diseases within the 6 months (180 days) prior to screening that remain unresolved, or current acute or chronic illnesses that may significantly affect the metabolism or safety evaluation of the investigational product.
4. History of autoimmune diseases or chronic hepatitis.
5. History of seizures, epilepsy, psychiatric or neurological disorders, or family history of seizures or epilepsy.
6. Major surgery within the 3 months (90 days) prior to screening, or surgery that may significantly affect the metabolism or safety evaluation of the investigational product.
7. Previous vaccination with human rabies vaccine, or suspected history of rabies exposure (defined as bites, scratches, licks on mucous membranes or broken skin by rabid, suspected rabid, or undetermined rabies status animals, or direct contact of open wounds or mucous membranes with saliva or tissues potentially containing rabies virus), as determined by inquiry.
8. Positive screening for anti-rabies virus antibodies during the screening period.
9. Vaccination with any vaccine other than the rabies vaccine within the 1 month (30 days) prior to screening.
10. Use of other antibody-based drugs or immunoglobulins within the 3 months (90 days) prior to screening.
11. Use of passive immunizing agents, immunosuppressants, or corticosteroids within the 3 months (90 days) prior to screening.
12. Use of medications that may affect the metabolism or safety evaluation of the investigational product within the 14 days prior to screening or ongoing use of such medications.
13. Participation in any clinical trial involving the use of investigational drugs or devices within the 3 months (90 days) prior to screening, or planned participation in other clinical trials during this study.
14. Regular alcohol consumption within the 3 months (90 days) prior to screening, averaging more than 2 alcohol units per day (1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% spirits, or 147 mL of 12% wine), or inability to abstain from alcohol during the trial period.
15. Smoking habit within the 3 months (90 days) prior to screening (more than 5 cigarettes or equivalent tobacco per day), or inability to abstain from smoking during the trial period.
16. Blood loss/donation exceeding 300 mL (excluding physiological blood loss in females) within the 3 months (90 days) prior to screening, receipt of blood transfusions or blood products, or plans to donate blood within 1 month (30 days) after the trial.
17. Inability to avoid strenuous exercise within 14 days after dosing.
18. History of drug abuse.
19. Pregnant or breastfeeding women.
20. History of needle or blood phobia, poor vascular condition, or intolerance to venipuncture.
21. Participants who may be unable to cooperate in completing the study for other reasons or are deemed unsuitable for inclusion by the investigator.
Primary outcome measure(s)
- Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine. — At least 30 minutes after administration
Local and systemic adverse events (AEs)
- Occurrence of any local AEs, systemic AEs, and serious adverse events (SAEs) from the administration of the investigational product on Day 0 until the last visit. — 0-105 days
Local AEs, systemic AEs, and serious adverse events (SAEs)
- Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine. — 0-105 Days
Tympanic temperature（℃）
- Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine. — 0-105 Days
Systolic Pressure and Diastolic Pressure (Sitting Position) （mmHg）
- Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine. — 0-105 Days
Pulse（bpm）
- Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
12-lead electrocardiogram（Heart Rate，bpm）
- Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
12-lead electrocardiogram（ Heart Rhythm）
- Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
12-lead electrocardiogram（ST Segment，mV）
- Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
12-lead electrocardiogram（Abnormal Q Wave，ms）
- Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Chest X-ray（Cardiothoracic Ratio，\>0.5）
- Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Chest X-ray（Pulmonary Nodule Size，mm）
- Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Chest X-ray（Costophrenic Angle，cm）
- Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Chest X-ray（Tracheal Position，cm）
- Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
White Blood Cell Count（×10⁹/L）
- Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Hemoglobin（g/L）
- Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Platelet Count（×10⁹/L）
- Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Neutrophil Percentage（%）
- Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Protein（g/L）
- Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Glucose（mmol/L）
- Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
White Blood Cells in Urine（/μL）
- Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Urine Erythrocytes （/μL）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Blood Glucose （mmol/L）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Potassium （mmol/L）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Creatinine （µmol/L）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Alanine Aminotransferase（U/L）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
Sodium（mmol/L）
- Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 Days
estimated Glomerular Filtration Rate（mL/min/1.73m²）
- Changes in routine coagulation test results from baseline at different observation time points following administration of the investigational product/vaccine. — 0-105 days
Prothrombin Time（s）
- Pharmacodynamic Endpoints — 0-105 Days
The positive rate (with a positivity threshold of RVNA ≥ 0.5 IU/mL) of serum rabies virus neutralizing antibodies (RVNA) were measured at the following time points: within 1 hour before the administration of the investigational product on Day 0, and at 4 hours, 6 hours, 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine.
- Pharmacodynamic Endpoints — 0-105 Days
The geometric mean concentration (GMC) of serum rabies virus neutralizing antibodies (RVNA) were measured at the following time points: within 1 hour before the administration of the investigational product on Day 0, and at 4 hours, 6 hours, 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Lanzhou Institute of Biological Products Co., Ltd. |
Lanzhou |
Gansu |
|
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