Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06083623
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-16
First Post:
2023-09-10
Brief Title:
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
Sponsor:
Zhuhai Trinomab Pharmaceutical Co Ltd
Organization:
Zhuhai Trinomab Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled and Parallel Group Adaptive Phase 2b3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GA35 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 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20232792 | OTHER | ENTER FOR DRUG EVALUATION NMPA | None |