A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Timeline

Start

2023-09-11

Primary completion

2025-06-16

Completion

2025-11-05

Outcome

Met primary endpoint

release “其Ⅲ期临床研究结果显示，单剂肌肉注射后，显著降低了健康足月和晚期早产儿由RSV引起的下呼吸道感染发生率” trinomab.com ↗

Drugs

Indications