NCT05630573

A Study of TNM001 in Chinese Healthy Preterm and Term Infants

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ib/IIa Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TNM001 Injection in Chinese Healthy Preterm and Term Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants. The main questions it aims to answer are: * the safety and tolerability of TNM001 injection * the pharmacokinetic (PK) profile of TNM001

Detailed description

This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	TNM001	intramuscular injection
BIOLOGICAL	Placebo	intramuscular injection

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-11-29
• Last updated: 2024-06-28

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study