BXOS110 Injection in the Treatment of Acute Ischaemic Stroke

Inclusion Criteria:

1. Age18~85 (including 18 and 85 years)，no gender limitation;
2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines forClinical Management of Cerebrovascular Disease (2nd edition);
3. 6 ≤ NIHSS score ≤ 20 before randomisation;
4. Within 3h of stroke onset and expected to be able to start receiving theinvestigational product within 3 h of stroke onset (note: stroke onset time wascalculated from the onset time of stroke symptoms; if stroke onset occurs duringsleep, the stroke onset time should be taken as the latest normal appearance time);
5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
6. Subjects who are able to understand and comply with the study procedures, and whoagree to sign the study informed consent form in writing to indicate that they arewilling to participate in the trial (the informed consent form can be signed bysubjects or their legal representatives).

Exclusion Criteria:

1. Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epiduralhematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage,traumatic cerebral hemorrhage, etc.);
2. Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
3. After aggressive antihypertensive therapy, hypertension still not under control:systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
4. Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
5. Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstableangina pectoris, acute myocardial infarction, and severe arrhythmias within theprevious 6 months, as determined by the investigators to be severe heart disease,affected participants;
6. Previously diagnosed severe hepatic and renal dysfunction and determined by theinvestigators as affect the subjects;
7. Patients who have been treated with neuroprotective agents after current stoke onset;
8. Have a epilepsy history or have epilepsy symptoms after current stoke onset;
9. Combined with other mental illnesses, resulting in inability or unwillingness tocooperate;
10. Combined with claudication, osteoarthropathy, etc., resulting in limb movementdysfunction, which is determined by investigators to affect neurological functiontest;
11. History of severe head trauma or stroke within 3 months before screening;
12. History of severe food or drug allergy, or known allergy to the investigational drugand its excipients;
13. Expected survival period is less than 3 months;
14. Pregnant, planning pregnancy or breastfeeding patients;
15. Suspected or confirmed history of alcohol or drug abuse;
16. Participated in other drug or device clinical trial within the 3 months prior toscreening or are participating in a other clinical trial;
17. Other conditions, and the investigator assessed that participation in the study mightincrease the patient's risk or that participation in the study was deemedinappropriate by the investigator.