A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

Launched by GENRIX (SHANGHAI) BIOPHARMACEUTICAL CO., LTD. · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called GR2001 to see how well it works and how safe it is for preventing tetanus, especially in people who may have been exposed to the bacteria through dirty or contaminated wounds. The trial will compare GR2001 with a standard treatment called Human Tetanus Immunoglobulin (HTIG). It is currently looking for participants who are at least 18 years old, are Chinese adults, and have experienced a potential tetanus exposure.

If you join this study, you will receive either the GR2001 injection or the standard treatment on the first day of the trial. It's important to know that some people cannot participate, including those with known allergies to the products being tested, anyone who is already diagnosed with tetanus, or pregnant women. Before joining, participants will need to provide written consent to confirm they understand the study. This trial aims to enhance our understanding of tetanus prevention and ensure that treatments are safe and effective for everyone.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Chinese male or female adults aged ≥ 18 years；
• • 2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
• • 3. Participants who provide signed written informed consent form.
• Exclusion Criteria:
• • 1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
• • 2. Suspect or diagnosed as tetanus;
• • 3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
• • 4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
• • 5. Females who are pregnant or with pregnancy test positive.