drugset / Trial / NCT06607380

A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine

NCT06607380

Phase 1 Completed 60 enrolled Zhuhai Trinomab Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.

Timeline

Start
2022-08-13
Primary completion
2023-04-10
Completion
2023-04-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adsorbed tetanus vaccine Vaccine Intramuscular
Subject SILTARTOXATUG Monoclonal antibody Intramuscular

Indications