Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1

Rabies Virus Infection Clinical Trial

Official title: Multicenter, Randomized, Double-blind, Placebo / Positive Control Evaluation of the First Safety, Pharmacokinetic and Pharmacodynamic Phase I Clinical Trial of Rabies Monomab CBB 1 in Healthy People

Status Not yet recruiting

Clinical Trial Summary

rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults

Clinical Trial Description

1. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity of rabies virus after single doses of rabies mAb CBB 1 or rabies human immunoglobulin (HRIG) in healthy adults.

2. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity characteristics of rabies virus after different doses of rabies mAb CBB 1 combination vaccine or HRIG combination vaccine in healthy adults.

3. Comparison of different doses of rabies mAb CBB 1 alone, different doses of rabies mAb CBB 1, combination vaccine or HRIG combination vaccine used in healthy adults after safety, tolerability, pharmacokinetics, rabies virus neutralization antibody activity and immunogenicity characteristics, further evaluation of drug interaction, for subsequent clinical trials to explore the optimal dose. ;

Related Conditions & MeSH terms

• Rabies
• Rabies Virus Infection

• NCT number: NCT05832073
• Study type: Interventional
• Source: Changchun BCHT Biotechnology Co.
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 30, 2023
• Completion date: April 30, 2024