Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke

Inclusion Criteria:

1. Age 18-80 years old (including upper and lower limits);

2. Clinically diagnosed as acute ischemic stroke according to the latest guidelines;

3. Patients with acute ischemic stroke who plan to receive or have received standardintravenous thrombolysis in hospital (this research center) within 8h after theonset of the disease;

4. Participants who have NIHSS ≥5 and ≤ 22 before thrombolysis;

5. Pre-stroke mRS Score ≤1;

6. Participants or legally authorized representatives who are able and willing to signinformed consent.

Exclusion Criteria:

1. Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke,epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoidhemorrhage, etc.;

2. Severe disturbance of consciousness: patients with NIHSS 1a consciousness level itemscore ≥2;

3. Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated alarge anterior circulation cerebral infarction (ASPECT score < 6 or infarct areagreater than 1/3 of the middle cerebral artery blood supply area);

4. Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acuteischemic symptoms suspected to be caused by other causes;

5. Patients who are ready to receive or have receive intravascular therapy;

6. After the onset of the disease, drugs with neuroprotective effects have been appliedin the instructions. Such as commercially available Edaravone, Edaravone andDexborneol Concentrated Solution for Injection, Butylphthalide, Nimodipine,Ganglioside, Citicoline, Piracetam, Oxiracetam, Human Urinary Kallidinogenase,Cinepazide, Mouse Nerve Growth Factor For Injection, Cerebrolysin, DeproteinisedCalf Blood Serum Injection, Deproteinised Calf Blood Extractives Injection, etc.;

7. Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after taking antihypertensive drugs before thrombolysis;

8. Severe renal insufficiency: serum creatinine >2 times the upper limit of normal orcreatinine clearance (CLcr)< 30mL/min (Cockcroft-Gault formula), or other knownsevere renal insufficiency; (Note: Cockcroft-Gault formula: ① Male: CLcr (mL/min) = [140 - age (yrs)]× body weight (kg) / [0.814 × serum creatinine (μmol/L)]; (2)female: CLcr (mL/min) = {[140 - age (years old)] by weight (kg) / [0.814 x serumcreatinine (μmol/L)]} x 0.85)

9. Severe liver function impairment: Alanine aminotransferase (ALT) or Aspartateaminotransferase(AST)>3 times the upper limit of normal, or other known liverdiseases such as acute and chronic hepatitis, cirrhosis, etc.;

10. Patients with a heart function rating above Class II (according to the New YorkHeart Association (NYHA) heart function rating) or a history of congestive heartfailure;

11. Patients with concurrent malignant tumors or undergoing anti-tumor therapy;

12. Allergic to experimental drugs or similar ingredients or materials used in imagingexaminations;

13. Patients during pregnancy, breastfeeding or planning pregnancy;

14. Patients who have a history of epilepsy or have had seizure-like symptoms at theonset of stroke, or suffer from serious mental disorders, intellectual disabilitiesor dementia;

15. Suspected or confirmed alcohol dependence, or drinking more than 3 units (male) or 2units (female) of alcohol within 24 hours prior to onset (1 unit =360 mL beer or 45mL liquor with 40% alcohol or 150 mL wine);

16. Patients have participated in or are participating in another clinical study withinthe 3 months before singing informed consent;

17. Patients who are judged unsuitable for participation by the investigators in thestudy.