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

Phase 2

Completed

• Conditions: Tetanus
• Interventions: Biological: TNM002 (low dose); Biological: TNM002 (medium dose); Biological: TNM002 (high dose); Biological: HTIG; Biological: Placebo

• Registration Number: NCT05625477
• Lead Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-18
• Primary Completion: 2022-05-29
• Study Completion: 2022-10-18
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-23
• Status Verified: 2023-05
• Disposition First Submitted: 2023-05-18
• Results First Submitted: 2025-06-22
• Results First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Results First Posted: 2025-09-16
• Disposition First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNM002 low dose	TNM002 (low dose)	Participants receive a single intramuscular injection of TNM002 with low dose on Day 1
TNM002 medium dose	TNM002 (medium dose)	Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1
TNM002 high dose	TNM002 (high dose)	Participants receive a single intramuscular injection of TNM002 with high dose on Day 1
Human Tetanus Immunoglobulin (HTIG)	HTIG	Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1
Placebo	Placebo	Participants receive a single intramuscular injection of placebo on Day 1

Primary Outcome Measures

Name	Time	Method
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level	At 24 hours 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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose	Up to 105 (±7) days post dosing	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.
Maximum Concentration (Cmax) of TNM002	Up to 105 days post dosing	The peak serum concentration of TNM002 observed after administration.
Time to Maximum Concentration (Tmax) of TNM002	Up to 105 days post dosing	The time point at which the Cmax is observed following TNM002 administration.
Elimination Half-life (t1/2) of TNM002	Up to 105 days post dosing	The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002	Up to 105 days post dosing	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.
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002	Up to 105 days post dosing	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.
Positive Rate of ADA in Volunteers in TNM002 Groups	Up to 105 days post dosing	The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.

Trial Locations

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