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

Zhuhai Trinomab Pharmaceutical Co., Ltd.2 sites in 1 country315 target enrollmentNovember 28, 2024

ConditionsRespiratory Syncytial Virus Infections

InterventionsTNM001 placebo

DrugsTNM001 placebo

Overview

Phase: Phase 3
Intervention: TNM001
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Enrollment: 315
Locations: 2
Primary Endpoint: Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 28, 2024

End Date

December 14, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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