NCT06548139

Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials

Multicenter, Randomized, Double-blind, Positive Control Evaluation of Rabies Monomab CBB 1 Combination Vaccine for Antibody Neutralization Activity and Safety Phase Clinical Trials in Healthy People

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people

Detailed description

To evaluate the rabies virus neutralizing antibody (RVNA) activity of rabies mAb CBB 1 in combination with human rabies vaccine (Vero cells) in healthy volunteers. To evaluate the safety and tolerability of rabies mAb CBB 1 compared to HRIG in combination with human rabies vaccine (Vero cells) in healthy volunteers. To evaluate the immunogenicity of rabies mAb CBB 1.

Conditions

• Rabies Virus Infection

Interventions

Type	Name	Description
DRUG	Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg	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	Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg	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
BIOLOGICAL	Lyophilized rabies vaccine for human use (Vero cells)	Active ingredient: inactivated rabies virus fixed poison

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

1 site across 1 country: China