Phase 2
N=240
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT05625477 ↗Enrolled (actual)
240
Serious AEs
0.4%
Results posted
Sep 2025
Primary outcome: Primary: Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level — 56; 61; 29; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TNM002 (low dose) (Biological); TNM002 (medium dose) (Biological); TNM002 (high dose) (Biological); HTIG (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level |
58; 61; 29; 55; 61; 61 | — |
| SECONDARY Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) |
0.0450; 0.1095; 0.2094; 0.0200; 0.0687; 0.1665 | — |
| SECONDARY Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level |
58; 61; 29; 55; 61; 61 | — |
| SECONDARY Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose |
NA; NA; NA; 59 | — |
| SECONDARY Maximum Concentration (Cmax) of TNM002 |
460; 967; 1710 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of TNM002 |
312; 311; 144 | — |
| SECONDARY Elimination Half-life (t1/2) of TNM002 |
586; 596; 661 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 |
524000; 1080000; 1810000 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 |
589000; 1180000; 1990000 | — |
| SECONDARY Positive Rate of ADA in Volunteers in TNM002 Groups |
3; 3; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05625477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.