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NCT05664750
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
Conditions: Tetanus
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 675
Sponsor: Trinomab Biotech Co., Ltd.
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Chinese male or female adults aged ≥ 18 years;Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;Participants who provide signed written informed consent form.Exclusion Criteria: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;Suspect or diagnosed as tetanus;Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;Any clinically significant chronic or acute medical condition that makes the subject unsuitable for participation;Current alcohol abuse, drug abuse or drug addictionOther protocol defined Inclusion/Exclusion criteria may apply
Source: ClinicalTrials.gov (NCT05664750). StuddyBuddy aggregates publicly available trial information.