Trials / Completed
CompletedNCT05664750
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 675 (actual)
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNM002 | Dosage Form: Injection, solution Route of administration: IM gluteal injection |
| DRUG | Human tetanus immunoglobulin (HTIG) | Dosage Form: Injection, solution Route of administration: IM gluteal injection |
Timeline
- Start date
- 2022-12-22
- Primary completion
- 2023-03-24
- Completion
- 2023-07-07
- First posted
- 2022-12-27
- Last updated
- 2024-03-08
Locations
28 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05664750. Inclusion in this directory is not an endorsement.