drugset / Trial / NCT06939777

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants

NCT06939777

Phase 1/2 Completed 255 enrolled Sinovac Life Sciences Co., Ltd.
RandomizedSequentialQuadruple-blindPrevention

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the full human anti-tetanus toxin monoclonal antibody SNA02-48 injection and compare the Tetanus-antibody levels and safety of SNA02-48 with human tetanus immunoglobulin (HTIG) in Chinese adult participants.

Timeline

Start
2025-04-28
Primary completion
2025-12-08
Completion
2026-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Human tetanus immunoglobulin Protein / enzyme biologic Intramuscular
Subject SNA02-48 Monoclonal antibody Intramuscular
Subject tetanus toxoid Vaccine Intramuscular

Indications