Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507813
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Multicenter Randomized Double-blind Controlled Study to Evaluate Pharmacokinetics Safety and Efficacy of ADC189 TabletsGranules in Children 2-11 Years Old With Influenza
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently there is only one treatment which only need one single oral dose for influenza in children five years above Baloxavir marboxil in China This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective
This is a multicenter randomized double-blind controlled Phase III clinical study
The study evaluates the pharmacokinetics safety and efficacy of ADC189 tabletsgranules following a single oral dose in children aged 2 to 11 years with influenza
This is a multicenter randomized double-blind controlled Phase III clinical study
The study evaluates the pharmacokinetics safety and efficacy of ADC189 tabletsgranules following a single oral dose in children aged 2 to 11 years with influenza
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None