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Completed

NCT Number: NCT05625477

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

HTIG

Biological

Single dose of HTIG administered by intramuscular injection

Placebo

Biological

Single dose of placebo administered by intramuscular injection

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Maximum Concentration (Cmax) of TNM002

    Time frame: Up to 105 days post dosing

    The peak serum concentration of TNM002 observed after administration.

  5. Time to Maximum Concentration (Tmax) of TNM002

    Time frame: Up to 105 days post dosing

    The time point at which the Cmax is observed following TNM002 administration.

  6. Elimination Half-life (t1/2) of TNM002

    Time frame: Up to 105 days post dosing

    The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.

  7. Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002

    Time frame: 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.

  8. Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002

    Time frame: 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.

  9. Positive Rate of ADA in Volunteers in TNM002 Groups

    Time frame: Up to 105 days post dosing

    The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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