SY007 in Patients With Acute Ischemic Stroke

Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects

This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.

Key Inclusion Criteria:

• Aged from18 Years to 80 Years
• Within 24h after the onset of stroke symptoms (time the patient was last seen well)
• Score range from 4 to 20 points, inclusive, on the NIHSS at randomization
• Prior to index stroke, patient was able to perform basic activities of daily living without assistance, mRS score≤1
• Absence of intracranial hemorrhage on brain CT or MRI
• Patients or legal representatives can give informed consent

Key Exclusion Criteria:

• Venous thrombolytic therapy or endovascular treatments have been applied for patients; or Patients plan to conduct these kind of treatments.
• Glasgow score of Patients ≤8
• Patients are receiving oral anticoagulants or INR>3.0
• Baseline blood platelet counts <80*109/L
• NIHSS score could not been obtained at baseline
• FPG levels < 50mg/dL or >400mg/dL
• Patients with Kidney disorder eGFR <30 mL/min or patients need dialysis
• Patients with Acute and Chronic hepatitis, or Liver diseases (AST or/and ALT >2 × ULN(upper limit normal))
• systolic blood pressure≥220mmHg or/and diastolic blood pressure≥120mmHg ; or Blood pressure under 90/60mmHg.