A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.

Exclusion Criteria18

• Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
• Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
• After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
• Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
• Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
• Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
• Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
• Patients who have been treated with neuroprotective agents after current stoke onset;
• Have a epilepsy history or have epilepsy symptoms after current stoke onset;
• Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
• Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
• History of severe head trauma or stroke within 3 months before screening;
• History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
• Expected survival period is less than 3 months;
• Pregnant, planning pregnancy or breastfeeding patients;
• Suspected or confirmed history of alcohol or drug abuse;
• Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
• Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.