A Study of B2065 in Patients With Acute Ischemic Stroke

Inclusion criteria

• Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.
• Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).
• Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).
• NIHSS score at screening is 8 to 20.
• The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.

Exclusion criteria

• Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.
• Modified Rankin Scale (mRS) score ≥2 before stroke onset.
• Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.
• Patients who are unable to undergo CT and/or MRI examinations.
• Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
• Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.
• Body temperature >38°C prior to dosing, and the investigator assesses that there is a risk of infection.
• Patients with uncontrollable active infection; or patients who have received systemic anti-infective therapy within 7 days prior to dosing and, in the investigator's judgment, may be likely to convert to uncontrollable active infection in the short term.
• Patients with current or prior severe diseases of other organ systems, including but not limited to:

• Patients with severe heart failure (NYHA Class III or IV) and/or severe respiratory failure;
• Patients with renal disease with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²;
• Advanced liver disease, such as hepatitis or liver cirrhosis;
• Patients positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); patients positive for hepatitis B e antibody (HBeAb) and/or hepatitis B core antibody (HBcAb) with quantitative HBV-DNA above the upper limit of normal; patients with any of the following test results positive: hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab);
• Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and/or diastolic blood pressure ≥110 mmHg;
• Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL).
• Screening laboratory tests meeting any of the following criteria:

• Serum alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN);
• Serum aspartate aminotransferase (AST) ≥3× ULN;
• Serum creatinine (Cr) ≥2× ULN;
• Absolute neutrophil count (ANC) <1.5×10^9/L;
• Platelet count (PLT) <100×10^9/L;
• Hemoglobin (Hgb) <90 g/L;
• International normalized ratio (INR) >1.7 or activated partial thromboplastin time (APTT) >1.25× ULN.
• Patients with malignant tumors or other diseases with an expected survival of less than 2 years.
• Patients with other acquired or congenital immunodeficiency diseases, or those currently using immunosuppressants.
• Patients who, upon screening inquiry, have alcohol dependence or a history of drug abuse.
• Pregnant or breastfeeding women; or those who plan to conceive, donate sperm, or donate oocytes during the trial and/or are unwilling to take effective contraception measures.
• Patients who participated in any other clinical trial within 1 month prior to screening.
• Patients who are allergic to any component of the investigational product.
• Patients deemed by the investigator to be unsuitable for participation in this trial.