Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE2
PHASE3
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Receipt of RSV vaccine or mAb
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
2250 Patients enrolled
Trial Details
Trial ID
NCT06083623
Start Date
October 6 2023
End Date
August 31 2026
Last Update
October 16 2023
Active Locations (39)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
2
Children's Hospital Capital Institute Pediatrics
Beijing, Beijing Municipality, China, 100020
3
Jiangjin Central Hospital
Chongqing, Chongqing Municipality, China, 400000
4
Xiamen maternal and Child Health Hospital
Xiamen, Fujian, China, 361003