Trials / Completed
CompletedNCT05625477
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TNM002 (low dose) | Single dose of TNM002 administered by intramuscular injection |
| BIOLOGICAL | TNM002 (medium dose) | Single dose of TNM002 administered by intramuscular injection |
| BIOLOGICAL | TNM002 (high dose) | Single dose of TNM002 administered by intramuscular injection |
| BIOLOGICAL | HTIG | Single dose of HTIG administered by intramuscular injection |
| BIOLOGICAL | Placebo | Single dose of placebo administered by intramuscular injection |
Timeline
- Start date
- 2022-04-18
- Primary completion
- 2022-05-29
- Completion
- 2022-10-18
- First posted
- 2022-11-23
- Last updated
- 2025-09-16
- Results posted
- 2025-09-16
Locations
4 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05625477. Inclusion in this directory is not an endorsement.