Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206720
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-12-28
Brief Title:
A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
Sponsor:
Vigonvita Life Sciences
Organization:
Vigonvita Life Sciences
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase IIIII Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus
Status:
RECRUITING
Status Verified Date:
2024-04
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 mgkgBID middle-dose group 20 mgkgBID and high-dose group 20 mgkgTID 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 mgkgBID middle-dose group 20 mgkgBID and high-dose group 20 mgkgTID 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:
None
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?:
None
Is an FDA AA801 Violation?:
None