Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342921
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-12
Brief Title:
ADC189 Tablets on Influenza A Virus InfectionInfluenza B Virus Infection
Sponsor:
Jiaxing AnDiCon Biotech CoLtd
Organization:
Jiaxing AnDiCon Biotech CoLtd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase IIIII Study of the Safety and Efficacy of ADC189 Tablets in the Treatment of Influenza A Virus InfectionInfluenza B Virus Infection in Adolescents and Adults
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ADC
Brief Summary:
The goal of this Phase IIIII study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infectioninfluenza B virus infection
The main aim to answer
Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative All the results will be used to design the Phase III study
Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza
Participants will be taken ADC189 tebletsPlacebo once and be observed by 22 days
Phase II study has 3 groups 15 mg ADC189 45 mg ADC189 and Placebo Phase III study has 2 groups 45 mg ADC189 and Placebo
The main aim to answer
Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative All the results will be used to design the Phase III study
Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza
Participants will be taken ADC189 tebletsPlacebo once and be observed by 22 days
Phase II study has 3 groups 15 mg ADC189 45 mg ADC189 and Placebo Phase III study has 2 groups 45 mg ADC189 and Placebo
Detailed Description:
None
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