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drugset / Trial / NCT05625477

Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

NCT05625477 ↗

Phase 2 Completed 240 enrolled Zhuhai Trinomab Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2022-04-18
Primary completion
2022-05-29
Completion
2022-10-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator HTIG Protein / enzyme biologic 250 iu Intramuscular
Subject SILTARTOXATUG Monoclonal antibody — Intramuscular

Indications

tetanus