drugset
drugset / Trial / NCT07149454

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

NCT07149454 ↗

Phase 1 Enrolling by invitation 68 enrolled Lanzhou Institute of Biological Products Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus toxin Monoclonal Antibody Injection in Healthy Participants.

Timeline

Start
2025-08-18
Primary completion
2026-05-27
Completion
2026-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Human tetanus immunoglobulin Protein / enzyme biologic — Intramuscular
Subject Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Monoclonal antibody 0.2 mg Intramuscular
Subject Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Monoclonal antibody 2 mg Intramuscular
Subject Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Monoclonal antibody 5 mg Intramuscular
Subject Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Monoclonal antibody 10 mg Intramuscular
Subject Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Monoclonal antibody 15 mg Intramuscular

Indications

tetanus