NCT07445815

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Lanzhou Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed description

Primary Objective of the study: （1）To evaluate the safety, tolerability, and Rabies Virus Neutralizing Activity (RVNA) of different doses of a recombinant human anti-rabies virus monoclonal antibody injection (referred to as the anti-rabies mAb), administered alone or in combination with a human rabies vaccine, compared to human rabies immune globulin, in healthy adult participants aged 18-60. Secondary Objective of the study: 1. To evaluate the pharmacokinetics (PK) of the anti-rabies mAb administered alone or in combination with a human rabies vaccine in healthy adult participants aged 18-60. 2. To evaluate the incidence of anti-drug antibodies for the anti-rabies mAb compared to human rabies immune globulin, administered alone or in combination with a human rabies vaccine, in healthy adult participants aged 18-60. 3. To provide a basis for dose selection for Phase III clinical studies.

Conditions

• Rabies (Healthy Volunteers)

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.
BIOLOGICAL	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.

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-07-29
• Completion: 2026-08-21
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: China