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ENROLLING BY INVITATION
NCT07149454
PHASE1

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

Sponsor: Lanzhou Institute of Biological Products Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2025-08-18

Completion Date

2026-06-24

Last Updated

2026-01-28

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

intramuscular injection

DRUG

Human Tetanus Immunoglobulin

intramuscular injection

DRUG

Placebo

intramuscular injection

Locations (1)

Lanzhou Institute of Biological Products Co., Ltd.

Lanzhou, Gansu, China