NCT06360250 - Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation | Biotech Hunter

Enrollment

190

Participants

Timeline

Start Date

April 10, 2024

Primary Completion Date

October 30, 2024

Study Completion Date

October 30, 2024

Conditions

Clostridium Tetanus

Interventions

DRUG

Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation

Each dose (1.0 ml) contained 1.25 mg of human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of human anti-tetanus toxin monoclonal antibody B86.

DRUG

Tetanus human immunoglobulin (HTIG)

DRUG

Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo

There were no active ingredients, and other ingredients were the same

BIOLOGICAL

Adsorbed tetanus vaccine (TT)

containing tetanus toxoid titer not less than 40 IU