Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517173
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Y-3 for Injection in the Treatment of Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Y-3 in Chinese Subjects with Acute Ischemic Stroke
Status:
RECRUITING
Status Verified Date:
2024-07
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:
NUWA-Y3
Brief Summary:
This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset
Detailed Description:
A multi-center randomized double-blind parallel placebo-controlled trial design was adopted and subjects were randomly assigned to Y-3 for injection group and placebo group in a 11 ratio randomization stratification factors include onset time 12 hours 12 hours and research site
Treatment was continued for 10 days 10 times and follow-up was conducted until the 90th day from the first dose
The trial is divided into three phases screeningbaseline phase treatment phase and follow-up phase
Screeningbaseline period After the subjects sign the informed consent form they enter the screeningbaseline period for screening examination
Treatment period Qualified subjects are randomly divided into groups in a 11 ratio and receive continuous treatment for 10 days 10 times with Y-3 for injection and placebo respectively During the treatment period relevant examinations and evaluations required by the protocol will be carried out PK blood samples from subjects were collected for population pharmacokinetic analysis
Follow-up period Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment
Treatment was continued for 10 days 10 times and follow-up was conducted until the 90th day from the first dose
The trial is divided into three phases screeningbaseline phase treatment phase and follow-up phase
Screeningbaseline period After the subjects sign the informed consent form they enter the screeningbaseline period for screening examination
Treatment period Qualified subjects are randomly divided into groups in a 11 ratio and receive continuous treatment for 10 days 10 times with Y-3 for injection and placebo respectively During the treatment period relevant examinations and evaluations required by the protocol will be carried out PK blood samples from subjects were collected for population pharmacokinetic analysis
Follow-up period Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment
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