NCT05832073

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

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: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Rabies Virus Infection

Interventions

Type	Name	Description
DRUG	Natural full human monoclonal antibody CBB 1 injection	Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
DRUG	Rabies Human Immunoglobulin (HRIG)	Active ingredient: Rabid human immunoglobulin
DRUG	Natural full human monoclonal antibody CBB 1 injection placebo	Composition: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
BIOLOGICAL	Lyophilized rabies vaccine for human use (Vero cells)	Active ingredient: inactivated rabies virus fixed poison

Timeline

• Start date: 2023-04-30
• Primary completion: 2023-12-30
• Completion: 2024-04-30
• First posted: 2023-04-27
• Last updated: 2023-04-27

Locations

1 site across 1 country: China