The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
Age18~85 (including 18 and 85 years)，no gender limitation;
Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
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);
Parallel
BXOS110
DrugBXOS110，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg
placebo
Drugplacebo，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg
Proportion of subjects with mRS score 0-2 on day 90
mRS/NIHSS /BI/EQ-5D score
1. Proportion of subjects with mRS score 0-1 on day 90; 2. Day 90 mRS Displacement Analysis;(The proportion of subjects with different mrs scores) 3. Proportion of subjects with NIHSS scores ≤1 or with a ≥4-point reduction in NIHSS score from baseline on day 10 (or at discharge); 4. Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation； 5. Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90; 6. Day 90 European Five Dimensional Health Scale (EQ-5D) Score.(The proportion of subjects with a score of 0)
Security Indicators
1. Incidence of serious adverse events (SAE) in each group; 2. Incidence of hypotension events in each group 3. Incidence of of hemorrhagic transformation events in each group ； 4. Incidence of adverse events (AE) in each group; 5. Incidence of all-cause mortality; 6. Mortality rate within 90 days due to stroke; 7. Changes in laboratory test indicators before and after treatment in each group; 8. Changes in vital signs before and after treatment in each group; 9. Changes in 12-lead ECG resuts before and after treatment in each group； 10. Situation of subjects withdrawn from the study for AE reasons.
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