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Completed
NCT05625477
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
Conditions: Tetanus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 240
Sponsor: Trinomab Biotech Co., Ltd.
Location: China
Summary
The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.
Eligibility Criteria
Inclusion Criteria:Chinese male or female adults aged ≥ 18 years;Healthy volunteers or volunteers with stable chronic diseases;Volunteers who provide signed written informed consent form.Exclusion Criteria:History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;History of alcohol or other substance abuse.
Source: ClinicalTrials.gov (NCT05625477). StuddyBuddy aggregates publicly available trial information.
