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NOT YET RECRUITING
NCT07445815
PHASE2

A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody

Sponsor: Lanzhou Institute of Biological Products Co., Ltd

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01-31

Completion Date

2026-08-21

Last Updated

2026-03-03

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Lanzhou Institute of Biological Products Co., Ltd.

Lanzhou, Gansu, China