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

Phase 3

Not yet recruiting

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: TNM001; Biological: placebo

• Registration Number: NCT06710925
• Lead Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study Start: 2024-11-30
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNM001	TNM001	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of medically attended LRTI due to RT-PCR confirmed RSV	150 days post dose

Trial Locations

Locations (2)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Sichuan, China