Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Brief Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
Sponsor:
Nanjing Zenshine Pharmaceuticals
Organization:
Nanjing Zenshine Pharmaceuticals
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
ZX-7101A-207
Brief Summary:
The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents
The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents
The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents
Detailed Description:
In this study adolescents aged 12 and 18 with uncomplicated influenza are selected as subjects Typical systemic andor respiratory influenza symptoms were required and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours This study is divided into screeningtreatment period D1 and observation period about 2 weeks You will be eligible before starting study therapy on day 1 D1 Participants were randomly assigned 11 to ZX-7101A group dose 40 mg administration once or placebo group dose 1 placebo tablet administration once with 180 participants planned to be included in each group for a total of about 360 participants
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