NCT06083623

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

A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,282 (actual)
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Accepted

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.

Detailed description

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants \[gestational age (GA)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	TNM001	single dose intramuscular injection
BIOLOGICAL	placebo	single dose intramuscular injection

Timeline

• Start date: 2023-09-11
• Primary completion: 2025-06-16
• Completion: 2025-11-05
• First posted: 2023-10-16
• Last updated: 2026-03-05

Locations

39 sites across 1 country: China

Regulatory

• FDA-regulated drug study