A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Phase 2

Not yet recruiting

• Conditions: Respiratory Syncytial Virus Infections

• Registration Number: NCT06083623
• Lead Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Detailed Description

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants \[gestational age (GA)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-10
• Study Start: 2023-10-06
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2250

Inclusion Criteria

• 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.

Exclusion Criteria

• 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
• 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
• 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
• 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. Prior history of a suspected or actual acute life-threatening event
• 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
• 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
• 10.Receipt of RSV vaccine or mAb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI	150 days post dose
Change in blood pressure (mmHg)	240 days post dose
Serum level of neutralizing antibody to RSV	240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints	240 days post dose
Occurrence of adverse events (AEs)	240 days post dose
Change in heart rate (beats per minute)	240 days post dose
Change in respiratory rate (breaths per min)	240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum	240 days post dose
Change in body temperature (celsius)	240 days post dose
Number of subjects with clinical significant abnormality in physical examinations	240 days post dose

Trial Locations

Locations (39)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Children's Hospital Capital Institute Pediatrics; 🇨🇳 Beijing, Beijing, China

Jiangjin Central Hospital; 🇨🇳 Chongqing, Chongqing, China

Xiamen maternal and Child Health Hospital; 🇨🇳 Xiamen, Fujian, China

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangdong, Guangdong, China

Guangdong Maternal and Child Health Care Hospital; 🇨🇳 Guangzhou, Guangdong, China

University of Chinese Academy of Sciense Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Affiliated Hospital of Guilin Medical University; 🇨🇳 Guilin, Guangxi, China

LiuZhou People's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Maternity and Child Health Care of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China

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