Status:
SUSPENDED
SY007 in Patients With Acute Ischemic Stroke
Lead Sponsor:
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 inject...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04891913
Start Date
July 1 2023
End Date
December 25 2023
Last Update
June 27 2022
Active Locations (1)
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1
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China