SY007 in Patients With Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Drug: SY-007/ Placebo 30mgDrug: SY-007/ Placebo 15mgDrug: SY-007/ Placebo 60mg
- Registration Number
- NCT04891913
- Lead Sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30mg SY-007/ Placebo Repeat Dose SY-007/ Placebo 30mg Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days. 15mg SY-007/ Placebo Repeat Dose SY-007/ Placebo 15mg Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days. 60mg SY-007/ Placebo Repeat Dose SY-007/ Placebo 60mg Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.
- Primary Outcome Measures
Name Time Method Safety and tolerance of SY-007 From Day 0 to Day 90 Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90 Day 8, Day30, Day60, Day 90 Excellent BI outcome is defined as a score of \>=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility.
Immunogenicity of SY-007 From Day 0 to Day 30 Anti-Drug antibody evaluation
Pharmacokinetics of SY-007 From Day 0 to Day 7 Volume of distribution
Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30 Day 8, Day30 Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90 Day 8, Day30, Day60, Day90 Excellent mRS is defined as mRS score of 0 or 1
Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30 Day 8, Day30 Change of Cerebral infarction volume before and after treatment Baseline, Day 8, Day30 Modified Rankin Scale Score at Day 8, Day30, Day60, Day90 Day 8, Day30, Day60, Day90 Modified Rankin Scale Score range from 0 to 5，higher score mean a worse outcome.
Trial Locations
- Locations (1)
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, China