MedTrace Logo

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

NCT07149454 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Tetanus

Interventions

DRUG

Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

intramuscular injection

DRUG

Human Tetanus Immunoglobulin

intramuscular injection

DRUG

Placebo

intramuscular injection

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianchang He · Yunnan Provincial Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149454 on ClinicalTrials.gov