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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

NCT05625477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-16

Study results available
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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.

Conditions

  • Tetanus

Interventions

BIOLOGICAL

TNM002 (low dose)

Single dose of TNM002 administered by intramuscular injection

BIOLOGICAL

TNM002 (medium dose)

Single dose of TNM002 administered by intramuscular injection

BIOLOGICAL

TNM002 (high dose)

Single dose of TNM002 administered by intramuscular injection

BIOLOGICAL

HTIG

Single dose of HTIG administered by intramuscular injection

BIOLOGICAL

Placebo

Single dose of placebo administered by intramuscular injection

Sponsors & Collaborators

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jie Hou · Peking University Care Luzhong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2022-05-29
Completion
2022-10-18
FDA Drug
Yes

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 NCT05625477 on ClinicalTrials.gov