Trials / Recruiting
RecruitingNCT06635798
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 582 (estimated)
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GR2001 | The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial. |
| BIOLOGICAL | HTIG | The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form. |
Timeline
- Start date
- 2024-09-03
- Primary completion
- 2024-12-04
- Completion
- 2025-03-04
- First posted
- 2024-10-10
- Last updated
- 2024-10-10
Locations
20 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06635798. Inclusion in this directory is not an endorsement.