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A Study of TNM001 in Chinese Healthy Preterm and Term Infants

NCT05630573 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-06-28

No results posted yet for this study

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

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

TNM001

intramuscular injection

BIOLOGICAL

Placebo

intramuscular injection

Sponsors & Collaborators

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hanmin Liu · West China Second Hospital, Sichuan University

  • Qin Yu · West China Second Hospital, Sichuan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630573 on ClinicalTrials.gov