drugset / Trial / NCT06635798
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
Timeline
- Start
- 2024-09-03
- Primary completion
- 2024-12-04
- Completion
- 2025-03-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GR2001 | Unknown | — | Intramuscular |
| Comparator | Human Tetanus Immunoglobulin | Protein / enzyme biologic | — | Intramuscular |