NCT06607380

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

A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine Administered Alone and Simultaneously Administered in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	TNM002	A single intramuscular (IM) gluteal injection
BIOLOGICAL	Adsorbed tetanus vaccine	A single IM deltoid injection
BIOLOGICAL	TNM002 + adsorbed tetanus vaccine	A single IM gluteal injection+ a single IM deltoid injection

Timeline

• Start date: 2022-08-13
• Primary completion: 2023-04-10
• Completion: 2023-04-17
• First posted: 2024-09-23
• Last updated: 2024-09-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study