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

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 Overview

• Status: Completed
• Conditions: Tetanus
• Intervention / Treatment: Biological: TNM002 (low dose); Biological: TNM002 (medium dose); Biological: TNM002 (high dose); Biological: HTIG; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China
      • The First Affiliated Hospital of Shantou University Medical College
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
  • Shandong
    • Zibo, Shandong, China
      • PKUcare Luzhong Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yunnan Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNM002 low dose; Participants receive a single intramuscular injection of TNM002 with low dose on Day 1	Biological: TNM002 (low dose); Single dose of TNM002 administered by intramuscular injection
Experimental: TNM002 medium dose; Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1	Biological: TNM002 (medium dose); Single dose of TNM002 administered by intramuscular injection
Experimental: TNM002 high dose; Participants receive a single intramuscular injection of TNM002 with high dose on Day 1	Biological: TNM002 (high dose); Single dose of TNM002 administered by intramuscular injection
Active Comparator: Human Tetanus Immunoglobulin (HTIG); Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1	Biological: HTIG; Single dose of HTIG administered by intramuscular injection
Placebo Comparator: Placebo; Participants receive a single intramuscular injection of placebo on Day 1	Biological: Placebo; Single dose of placebo administered by intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)	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. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.	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	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. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.	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	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. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.	Up to 105 (±7) days post dosing
Maximum Concentration (Cmax) of TNM002	The peak serum concentration of TNM002 observed after administration.	Up to 105 days post dosing
Time to Maximum Concentration (Tmax) of TNM002	The time point at which the Cmax is observed following TNM002 administration.	Up to 105 days post dosing
Elimination Half-life (t1/2) of TNM002	The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.	Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002	The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve.	Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002	The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity.	Up to 105 days post dosing
Positive Rate of ADA in Volunteers in TNM002 Groups	The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.	Up to 105 days post dosing

Collaborators and Investigators

• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jie Hou, Peking University Care Luzhong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): May 29, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Tetanus; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TNM002-P2-CH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No