HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.

Inclusion criteria

• Fully understand and voluntarily participate in this study, and sign the informed consent form;
• Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender;
• Onset of symptoms within 4.5 to 24 hours;
• Clinically diagnosed with acute ischemic stroke;
• Pre-stroke modified Rankin Scale (mRS) score < 2;
• National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 (inclusive) at screening;
• Meet the imaging inclusion criteria;
• Female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective contraception and avoid sperm/ova donation.

Exclusion criteria

• Treatment with thrombolytic therapy.
• Planned endovascular therapy.
• Arterial dissection of the head, neck, or aorta.
• Multiple infarctions across multiple large vascular territories.
• NIHSS level of consciousness item 1a score > 2.
• Neurological deficits presenting after a seizure or post-ictal state, or the presence of other neurological conditions leading to uncooperative or unwillingness to cooperate with examination.
• Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan.
• Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
• History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc.
• History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months.
• Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding.
• Major surgery or severe trauma within the past 2 weeks.
• Arterial puncture at a non-compressible site within the past week.
• Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment.
• Known significant bleeding tendency or severe coagulation disorder.
• Blood glucose at screening >22.2 mmol/L or <2.8 mmol/L; subjects may be re-evaluated after active treatment.
• Within the past 3 months: acute ST-segment elevation myocardial infarction (MI), and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or hospitalization for acute coronary syndrome, MI, cardiac arrest, or unplanned coronary intervention; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.
• Significant liver disease history, or AST and/or ALT and/or GGT ≥3 × ULN, and/or total bilirubin (TBIL) ≥2 × ULN, or known congenital disorder of bilirubin metabolism.
• Clinically significant severe renal disease, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
• History of hemolytic anemia due to various causes, currently under treatment or not meeting cure criteria.
• Known allergy or hypersensitivity to HRS-7450 or any excipients in its formulation.
• Treatment with therapeutic doses of heparin or low molecular weight heparin within 24 hours.
• Use of oral anticoagulants within 48 hours, including vitamin K antagonists, direct thrombin inhibitors, factor Xa inhibitors, or other investigational anticoagulants.
• Use of glycoprotein IIb/IIIa receptor inhibitors within 48 hours.
• Female subjects who are pregnant or breastfeeding, or with a positive pregnancy test.
• Participation in another drug or device clinical trial within the 3 months prior to screening.
• Terminal illness with a life expectancy of less than 1 year.
• Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.