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Completed

NCT Number: NCT05664750

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.

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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 3

Primary location

Hefei First People's Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese male or female adults aged ≥ 18 years;
  • Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
  • Participants who provide signed written informed consent form.

Exclusion criteria

  • Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins;
  • Suspect or diagnosed as tetanus;
  • Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
  • Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
  • Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

TNM002

Drug

Dosage Form: Injection, solution

Route of administration: IM gluteal injection

Human tetanus immunoglobulin (HTIG)

Drug

Dosage Form: Injection, solution

Route of administration: IM gluteal injection

Primary outcomes

  1. Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.

    Time frame: Baseline up to 12 hours after receipt of study drug

Secondary outcomes

  1. Tetanus protection rate (1 - tetanus incidence)

    Time frame: Up to 28 days after receipt of study drug

Other outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 105 days after receipt of study drug

  2. Incidence of treatment related adverse events (AEs)

    Time frame: Up to 105 days after receipt of study drug

  3. Incidence of serious adverse events (SAEs)

    Time frame: Up to 105 days after receipt of study drug

  4. The number and percentage of subjects with abnormal hematology tests

    Time frame: Up to 90 days after receipt of study drug

    The hemotology tests include red blood cell count, hemoglobin, platelet count, white blood cell count, absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocytes percentage, absolute monocyte count, and hematocrit

  5. The number and percentage of subjects with abnormal serum chemistry tests

    Time frame: Up to 90 days after receipt of study drug

    The serum chemistry tests include total protein, albumin, sodium, potassium, chloride, calcium, glucose, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, urea (blood urea nitrogen) and creatinine

  6. The number and percentage of subjects with abnormal urinalysis tests

    Time frame: Up to 90 days after receipt of study drug

    The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell

  7. The number and percentage of subjects with abnormal vital signs

    Time frame: Up to 90 days after receipt of study drug

    The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature

  8. The number and percentage of subjects with abnormal physical examination

    Time frame: Up to 90 days after receipt of study drug

    The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities.

  9. The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG)

    Time frame: Up to 90 days after receipt of study drug

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Mar 8, 2024

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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