The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

Prior treatment

• Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes.
• Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit.

Other illness

• Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc..
• Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2.
• History of severe hepatic impairment.
• History of severe renal insufficiency.
• Advanced malignancy or currently undergoing antineoplastic treatment.
• Terminal illness with an estimated life expectancy of less than 1 year.
• Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.

Lab values

• Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.

Other

• Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment.
• Severe hyperglycemia or hypoglycemia.
• Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening.

• Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative).
• Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
• Clinical diagnosis of acute ischemic stroke (AIS).
• Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
• National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2.