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

NCT05625477 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TNM002-P2-CH01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level

  The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL.

  At 24 hours post-dose

Secondary Outcomes (9)

• Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)

  At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose

• Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level

  At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose

• Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose

  Up to 105 (±7) days post dosing

• Maximum Concentration (Cmax) of TNM002

  Up to 105 days post dosing

• Time to Maximum Concentration (Tmax) of TNM002

  Up to 105 days post dosing

Study Arms (5)

TNM002 low dose

EXPERIMENTAL

Participants receive a single intramuscular injection of TNM002 with low dose on Day 1

Biological: TNM002 (low dose)

TNM002 medium dose

EXPERIMENTAL

Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1

Biological: TNM002 (medium dose)

TNM002 high dose

EXPERIMENTAL

Participants receive a single intramuscular injection of TNM002 with high dose on Day 1

Biological: TNM002 (high dose)

Human Tetanus Immunoglobulin (HTIG)

ACTIVE COMPARATOR

Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1

Biological: HTIG

Placebo

PLACEBO COMPARATOR

Participants receive a single intramuscular injection of placebo on Day 1

Biological: Placebo

Interventions

TNM002 (low dose) BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

TNM002 low dose

TNM002 (medium dose) BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

TNM002 medium dose

TNM002 (high dose) BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

TNM002 high dose

HTIG BIOLOGICAL

Single dose of HTIG administered by intramuscular injection

Human Tetanus Immunoglobulin (HTIG)

Placebo BIOLOGICAL

Single dose of placebo administered by intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (4)

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, China

Location

PKUCare Luzhong Hospital

Zibo, Shandong, China

Location

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Wenxi Xiang
• Organization: Zhuhai Trinomab Pharmaceutical Co., Ltd.

xiangwenxi@trinomab.com

18083065921

Study Officials

• Jie Hou

  Peking University Care Luzhong Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 23, 2022
• Study Start: April 18, 2022
• Primary Completion: May 29, 2022
• Study Completion: October 18, 2022
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2023-05

Locations

CN (4)