Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT05664750
Eligibility 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. 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. Current alcohol abuse, drug abuse or drug addiction
Other protocol defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05664750
Study Brief:
Protocol Section:
NCT05664750