A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
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
1 other identifier
interventional
200
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2026
CompletedStudy Start
First participant enrolled
January 31, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2026
ExpectedMarch 3, 2026
February 1, 2026
6 months
January 26, 2026
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (30)
Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.
Local and systemic adverse events (AEs)
At least 30 minutes after administration
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.
Local AEs, systemic AEs, and serious adverse events (SAEs)
0-105 days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Tympanic temperature（℃）
0-105 Days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Systolic Pressure and Diastolic Pressure (Sitting Position) （mmHg）
0-105 Days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Pulse（bpm）
0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（Heart Rate，bpm）
0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（ Heart Rhythm）
0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（ST Segment，mV）
0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（Abnormal Q Wave，ms）
0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Cardiothoracic Ratio，\>0.5）
0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Pulmonary Nodule Size，mm）
0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Costophrenic Angle，cm）
0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Tracheal Position，cm）
0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
White Blood Cell Count（×10⁹/L）
0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Hemoglobin（g/L）
0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Platelet Count（×10⁹/L）
0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Neutrophil Percentage（%）
0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Protein（g/L）
0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Glucose（mmol/L）
0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
White Blood Cells in Urine（/μL）
0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Urine Erythrocytes （/μL）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Blood Glucose （mmol/L）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Potassium （mmol/L）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Creatinine （µmol/L）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Alanine Aminotransferase（U/L）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Sodium（mmol/L）
0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
estimated Glomerular Filtration Rate（mL/min/1.73m²）
0-105 Days
Changes in routine coagulation test results from baseline at different observation time points following administration of the investigational product/vaccine.
Prothrombin Time（s）
0-105 days
Pharmacodynamic Endpoints
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.
0-105 Days
Pharmacodynamic Endpoints
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.
0-105 Days
Secondary Outcomes (11)
Pharmacokinetic Endpoints
105 Days
Pharmacokinetic Endpoints
105 Days
Pharmacokinetic Endpoints
105 Days
Pharmacokinetic Endpoints
105 Days
Pharmacokinetic Endpoints
105 Days
- +6 more secondary outcomes
Study Arms (7)
Group 1：40 IU/kg monoclonal antibody - Monotherapy Study
EXPERIMENTAL60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Group 2: 80 IU/kg monoclonal antibody - Monotherapy Study
EXPERIMENTAL60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Group 3: HRIG (20 IU/kg) group - Monotherapy Study
EXPERIMENTAL60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Group 4：40 IU/kg monoclonal antibody plus vaccine - Combined Administration Study
EXPERIMENTALA total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Group 5：80 IU/kg monoclonal antibody plus vaccine - Combined Administration Study
EXPERIMENTALA total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Group 6: HRIG (20 IU/kg) plus vaccine - Combined Administration Study
EXPERIMENTALA total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Group 7: placebo plus vaccine - Combined Administration Study
EXPERIMENTALA total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification.
- Participants voluntarily agree to participate in the study and sign an informed consent form.
- 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.
- 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).
- 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.
You may not qualify if:
- 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.
- Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).
- 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.
- History of autoimmune diseases or chronic hepatitis.
- History of seizures, epilepsy, psychiatric or neurological disorders, or family history of seizures or epilepsy.
- 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.
- 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.
- Positive screening for anti-rabies virus antibodies during the screening period.
- Vaccination with any vaccine other than the rabies vaccine within the 1 month (30 days) prior to screening.
- Use of other antibody-based drugs or immunoglobulins within the 3 months (90 days) prior to screening.
- Use of passive immunizing agents, immunosuppressants, or corticosteroids within the 3 months (90 days) prior to screening.
- 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.
- 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.
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lanzhou Institute of Biological Products Co., Ltd.
Lanzhou, Gansu, 730000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaolin Huang
Wuhan Jinyintan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2026
First Posted
March 3, 2026
Study Start
January 31, 2026
Primary Completion
July 29, 2026
Study Completion (Estimated)
August 21, 2026
Last Updated
March 3, 2026
Record last verified: 2026-02