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

Suzhou Yabao Pharmaceutical R&D Co., Ltd.1 site in 1 country36 target enrollmentJuly 1, 2023

ConditionsAcute Ischemic Stroke

InterventionsSY-007/ Placebo 15mg SY-007/ Placebo 30mg SY-007/ Placebo 60mg

DrugsSY-007/ Placebo 15mg SY-007/ Placebo 30mg SY-007/ Placebo 60mg

Overview

Phase: Phase 1
Intervention: SY-007/ Placebo 15mg
Conditions: Acute Ischemic Stroke
Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Enrollment: 36
Locations: 1
Primary Endpoint: Safety and tolerance of SY-007
Status: Suspended
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2023

End Date

December 25, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

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.

Arms & Interventions

15mg SY-007/ Placebo Repeat Dose

Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days.

Intervention: SY-007/ Placebo 15mg

30mg SY-007/ Placebo Repeat Dose

Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days.

Intervention: SY-007/ Placebo 30mg

60mg SY-007/ Placebo Repeat Dose

Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.

Intervention: SY-007/ Placebo 60mg

Outcomes

Primary Outcomes

Safety and tolerance of SY-007

Time Frame: From Day 0 to Day 90

Number of patients with treatment-emergent adverse events and number of patients who died over 90 days

Secondary Outcomes

Immunogenicity of SY-007(From Day 0 to Day 30)
Pharmacokinetics of SY-007(From Day 0 to Day 7)
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)
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)
Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90(Day 8, Day30, Day60, Day 90)