Y-3 for Injection in the Treatment of Acute Ischemic Stroke

Inclusion Criteria:

1. Age ≥ 18 years and < 81 years, male or female;

2. After onset of disease, ischemic stroke meeting the following characteristics: 7≤NIHSS(National Institutes of Stroke score)≤20 , and the sum of the scores of theitem 5 upper limb and item 6 lower limb ≥ 2 points. If patients receivedthrombolytic therapy, they would be screened and assessed by NIHSS score afterthrombolysis;

3. Within 48 hours (inclusive) of onset;

4. Patients who were diagnosed as ischemic stroke according to Key Points in Diagnosisof Various Major Cerebrovascular Diseases 2019 in China and recovered well after thefirst or last onset of disease (mRS score ≤ 1 point before this episode);

5. The patient or his/her legal representative voluntarily signed informed consent formapproved by the Ethics Committee.

Exclusion Criteria:

1. Intracranial hemorrhagic disease by cranial imaging: hemorrhagic stroke, epiduralhematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage,etc.; if it was only oozing, the investigator could determine whether it wassuitable for enrollment;

2. Severe disturbance of consciousness: NIHSS score > 1 on item 1a level ofconsciousness;

3. Transient ischemic attack (TIA);

4. Systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg afterblood pressure control;

5. Previous diagnosis of severe mental disorders and severe dementia;

6. Previously diagnosed with depression or anxiety;

7. Receiving antidepressant or anxiolytic therapy;

8. Have been diagnosed with severe active liver diseases, such as acute hepatitis,chronic active hepatitis, cirrhosis, etc.; or alanine aminotransferase or aspartateaminotransferase > 2.0 × upper limit of normal;

9. Have been diagnosed with severe active renal disease, renal dysfunction; or serumcreatinine > 1.5 × upper limit of normal;

10. After this episode, drugs with brain cell protective effect clarified in the packageinsert have been applied, such as commercially available edaravone,concentratedsolution of edaravone and dextranol for injection, nimodipine, ganglioside,citicoline, piracetam, oxiracetam, butylphenyl peptide, human urinary kininogenase (urinary kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (brainprotein hydrolysate), deproteinized calf serum injection, deproteinized calf bloodextract injection, etc.;

11. Thrombectomy or interventional therapy has been applied or planned after thisepisode;

12. Previous diagnosis of concurrent malignancy and ongoing anti-tumor therapy;

13. Previous diagnosis of severe systemic disease with expected survival times < 90days;

14. The patient is pregnant, lactating and the patient/patient's partner may becomepregnant and plans to become pregnant during the trial;

15. Previously known hypersensitivity to the product or any of its excipients (15-hydroxystearate polyethylene glycol, propylene glycol, mannitol, potassiumdihydrogen phosphate, dipotassium hydrogen phosphate trihydrate);

16. History of major surgery within 4 weeks prior to enrollment that impactsneurological score assessed by the investigator or impacts 90-day survival;

17. Participation in another clinical study within 30 days prior to randomization orongoing participation in another clinical study;

18. Investigator considered inappropriate for participation in this clinical study.