Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06206720
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
Sponsor:
Vigonvita Life Sciences
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.
Status:
COMPLETED
Status Verified Date:
2025-06
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:
To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.
Detailed Description:
This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.
It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.
It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: