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Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Dose-Finding Phase II Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo Following a Single Intramuscular Injection in Chinese Adult Volunteers

NCT05625477•Zhuhai Trinomab Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Chinese male or female adults aged ≥ 18 years;
•2. Healthy volunteers or volunteers with stable chronic diseases;
•3. Volunteers who provide signed written informed consent form.

Exclusion Criteria

•1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
•2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
•3. History of alcohol or other substance abuse.

Locations (4)

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

PKUCare Luzhong Hospital

Zibo, Shandong, China

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China

Key Dates

Start Date

April 18, 2022

Primary Completion Date

May 29, 2022

Completion Date

October 18, 2022

Last Updated

September 16, 2025

Enrollment

240

ACTUAL participants

Conditions

Tetanus

Interventions

TNM002 (low dose)

BIOLOGICAL

TNM002 (medium dose)

BIOLOGICAL

TNM002 (high dose)

BIOLOGICAL

HTIG

BIOLOGICAL

Placebo

BIOLOGICAL

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

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

A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand