NCT05832073 - Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1 | Biotech Hunter

Enrollment

152

Participants

Timeline

Start Date

April 30, 2023

Primary Completion Date

December 30, 2023

Study Completion Date

April 30, 2024

Conditions

Rabies Virus Infection

Interventions

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

Trial Locations (1)

650000

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Kunming