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NOT YET RECRUITING
NCT06548139
PHASE2

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

Sponsor: Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-07-31

Completion Date

2025-05-31

Last Updated

2024-08-12

Healthy Volunteers

Yes

Interventions

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

Locations (1)

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Kunming, Yunnan, China