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
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
582 participants
Sep 3, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Chinese male or female adults aged ≥ 18 years；
- Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
- Participants who provide signed written informed consent form.
Exclusion Criteria5
- Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
- Suspect or diagnosed as tetanus;
- Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
- Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
- Females who are pregnant or with pregnancy test positive.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06635798