Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke

PHASE3CompletedINTERVENTIONAL
Enrollment

614

Participants

Timeline

Start Date

April 25, 2023

Primary Completion Date

June 17, 2024

Study Completion Date

June 17, 2024

Conditions
Acute Ischemic Stroke
Interventions
DRUG

TTYP01 tablets

Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (60 mg) of investigational drug each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).

DRUG

Placebo (Simulant TTYP01 Tablets)

Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (0 mg) of placebo each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).

Trial Locations (1)

400042

Daping Hospital, Chongqing

All Listed Sponsors
lead

Shanghai Auzone Biological Technology Co., Ltd.

INDUSTRY