CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 240 enrolled
Drug / intervention
TNM002 (low dose) +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05625477
NCT05625477Phase 2Completed
CompareCT.gov

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

Zhuhai Trinomab Pharmaceutical Co., Ltd.·interventional·Posted Nov 23, 2022·Updated Sep 16, 2025

In Brief

A Phase 2 clinical trial evaluating TNM002 (low dose), TNM002 (medium dose), and 3 other interventions for Tetanus. Completed, enrolled 240 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedNov 23, 2022
Enrollment StartApr 18, 2022
Primary CompletionMay 29, 2022
Study CompletionOct 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.6 years ago

Interventions

TNM002 (low dose)biological

Single dose of TNM002 administered by intramuscular injection

TNM002 (medium dose)biological

Single dose of TNM002 administered by intramuscular injection

TNM002 (high dose)biological

Single dose of TNM002 administered by intramuscular injection

HTIGbiological

Single dose of HTIG administered by intramuscular injection

Placebobiological

Single dose of placebo administered by intramuscular injection