Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled Clinical Trial

Inclusion Criteria:

1. Fully understand and voluntarily participate in this study, and sign an informedconsent form (the informed consent form can be voluntarily signed by the individualor legal representative);

2. 18 ≤ Age ≤ 80 years old;

3. The onset time is within 4.5 to 24 hours, and medication can be completed within 24hours of onset (onset time is defined as the patient's last normal time);

4. Clinically diagnosed as acute ischemic stroke (diagnosis follows the ChineseGuidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);

5. mRS score ≤ 2 before the first episode;

6. When screening, the National Institutes of Health Stroke Scale (NIHSS) scores from 3to 25 (including both ends);

7. Female and male participants with fertility must agree to use efficientcontraception measures from the signing of the informed consent form until one monthafter the last administration of the investigational drug, without a birth plan, andwithout donating sperm/eggs. (See "Contraceptive methods" in the attachment fordetails).

Exclusion Criteria:

1. Treatment with ateplase, teneplase, or other thrombolytic drugs;

2. Proposed endovascular treatment;

3. Intracranial hemorrhagic diseases;

4. Aortic arch dissection;

5. NIHSS awareness score 1a>2 points;

6. Epileptic seizures or neurological dysfunction after seizures, or combined withother neurological/psychiatric disorders leading to uncooperative or non cooperativephysical examinations;

7. Non enhanced CT shows a low-density shadow greater than one-third of the bloodsupply area of the middle cerebral artery or an ASPECT score of less than 6 pointsin the anterior circulation;

8. Previous history of intracranial hemorrhage;

9. Intracranial tumors, arteriovenous malformations, and giant aneurysms;

10. Acute occlusion of the internal carotid artery due to carotid artery dissection;

11. Multiple infarcts in areas supplied by multiple large blood vessels;

12. Have a history of ischemic stroke, severe traumatic brain injury, or intracranial orspinal surgery in the past month;

13. Gastrointestinal or urinary system bleeding within the past 2 weeks;

14. Major surgical procedures or severe injuries within the past 2 weeks;

15. Arterial puncture that is difficult to compress and stop bleeding within the pastweek;

16. Active visceral bleeding;

17. After actively reducing blood pressure, systolic blood pressure ≥ 180mmHg and/ordiastolic blood pressure ≥ 100mmHg;

18. Screening period examination: Blood glucose<2.8 or>22.2mmol/L, platelet<100 * 109/L,other findings suggestive of a high risk of bleeding;

19. Within the past 3 months, acute ST segment elevation myocardial infarction (MI)and/or acute decompensated heart failure occurred, and/or QTc>520 milliseconds,and/or due to acute coronary syndrome MI、 Hospitalization or involuntary coronaryintervention for cardiac arrest; Or New York Heart Association Grade III/IV heartfailure; Or known to have ventricular tachycardia;

20. History of severe liver disease, or aspartate aminotransferase (AST) and/or alanineaminotransferase (ALT) and/or glutamyltransferase (GGT) ≥ 3 x ULN and/or totalbilirubin (TBIL) ≥ 2 x ULN.

21. Severe kidney disease with clinical significance, or eGFR<45mL/min/1.73 m2;

22. Subjects with known potential bleeding constitution or coagulation dysfunction;

23. Subjects with a known history of glucose-6-phosphate dehydrogenase deficiency or afamily history;

24. Known to be allergic to any component of HRS-7450 or its formulations or placebo;

25. Received therapeutic or prophylactic doses of heparin treatment within 24 hours;

26. Oral coumarin anticoagulants with an international standardized ratio INR>2.7;

27. Use thrombin inhibitors, Xa factor inhibitors, or other anticoagulant drugs understudy within48 hours;

28. Use platelet IIb/IIIa receptor inhibitors within 48 hours;

29. Pregnant women, or women of childbearing age who test positive for pregnancy, orthose who are breastfeeding;

30. Participate in clinical studies of other drugs or devices within the first threemonths of the screening period (sign an informed consent form and receive treatmentwith the trial drug/device);

31. The terminal state of the disease, with an expected survival period of no more than 1 year;

32. Other situations where the researcher deems it inappropriate to participate in thisexperiment.