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

NCT07445815 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-03

No results posted yet for this 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

Conditions

  • Rabies (Healthy Volunteers)

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.

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Chaolin Huang · Wuhan Jinyintan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-07-29
Completion
2026-08-21

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07445815 on ClinicalTrials.gov