Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

• Status: Not yet recruiting
• Trial end date: 2023-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trinomab Biotech Co., Ltd.
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years;

2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;

3. Participants who provide signed written informed consent form.

Exclusion Criteria:

1. Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins;

2. Suspect or diagnosed as tetanus;

3. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;

4. Any clinically significant chronic or acute medical condition that makes the subject unsuitable for participation;

5. Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply