A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants

March 3, 2026 updated by: Zhuhai Trinomab Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Monoclonal Antibody TNM001 Injection Against Respiratory Syncytial Virus in High-risk Infants

This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 sites in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Second University Hospital, Sichuan University
      • Chongqing, Sichuan, China, 404100
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
  • 2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection.
  • 3.Subject is available to complete the follow-up period.

Exclusion Criteria:

  • 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
  • 2. History of RSV infection
  • 3. Being hospitalized at the time of randomization
  • 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
  • 5. Renal impairment or hepatic dysfunction
  • 6. Nervous system disease or neuromuscular disease
  • 7. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
  • 8. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
  • 9.Receipt of RSV vaccine or mAb
  • 10.Receiving blood products before randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: placebo
single dose intramuscular injection
Experimental: TNM001
Biological: TNM001
single dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time Frame: 150 days post dose
150 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Hanmin Liu, West China Second Hospital, Sichuan University
  • Principal Investigator: Enmei Liu, Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Actual)

July 27, 2025

Study Completion (Actual)

December 14, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNM001-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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