CompletedPhase 2

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

China240 participantsStarted 2022-04-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: At 24 hours post-dose

Trial details

NCT IDNCT05625477

SponsorZhuhai Trinomab Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-29

Results submitted2025-06-22

View on ClinicalTrials.gov More Tetanus trials