SY007 in Patients With Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2022-12-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Criteria

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.