Clinical trial NCT04891913: SY007 in Patients With Acute Ischemic Stroke
Official title: Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerance of SY-007
timeFrame: From Day 0 to Day 90
Secondary outcomes:
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Pharmacokinetics of SY-007
timeFrame: From Day 0 to Day 7
measure: Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90
timeFrame: Day 8, Day30, Day60, Day90
measure: Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
timeFrame: Day 8, Day30, Day60, Day90
measure: Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30
timeFrame: Day 8, Day30
measure: Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30
timeFrame: Day 8, Day30
measure: Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90
timeFrame: Day 8, Day30, Day60, Day 90
measure: Change of Cerebral infarction volume before and after treatment
timeFrame: Baseline, Day 8, Day30
measure: Immunogenicity of SY-007
timeFrame: From Day 0 to Day 30
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Study officials:
References: