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SY007 in Patients With Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SY-007/ Placebo 15mg
SY-007/ Placebo 30mg
SY-007/ Placebo 60mg
Sponsored by
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

15mg SY-007/ Placebo Repeat Dose

30mg SY-007/ Placebo Repeat Dose

60mg SY-007/ Placebo Repeat Dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Safety and tolerance of SY-007
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days

Secondary Outcome Measures

Pharmacokinetics of SY-007
Peak Plasma Concentration (Cmax)
Pharmacokinetics of SY-007
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of SY-007
Time to Cmax (Tmax)
Pharmacokinetics of SY-007
Terminal half life (T½)
Pharmacokinetics of SY-007
Clearance (CL)
Pharmacokinetics of SY-007
Volume of distribution
Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90
Excellent mRS is defined as mRS score of 0 or 1
Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
Modified Rankin Scale Score range from 0 to 5，higher score mean a worse outcome.
Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30
Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30
Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at 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.
Change of Cerebral infarction volume before and after treatment
Immunogenicity of SY-007
Anti-Drug antibody evaluation

Full Information

First Posted
May 10, 2021
Last Updated
June 20, 2022
Sponsor
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04891913
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Suspended
Why Stopped
The sponsor decided to suspend the process
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Yabao Pharmaceutical R&D Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
15mg SY-007/ Placebo Repeat Dose
Arm Type
Experimental
Arm Description
Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days.
Arm Title
30mg SY-007/ Placebo Repeat Dose
Arm Type
Experimental
Arm Description
Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days.
Arm Title
60mg SY-007/ Placebo Repeat Dose
Arm Type
Experimental
Arm Description
Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.
Intervention Type
Drug
Intervention Name(s)
SY-007/ Placebo 15mg
Intervention Description
15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
SY-007/ Placebo 30mg
Intervention Description
30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
SY-007/ Placebo 60mg
Intervention Description
60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Primary Outcome Measure Information:
Title
Safety and tolerance of SY-007
Description
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
Time Frame
From Day 0 to Day 90
Secondary Outcome Measure Information:
Title
Pharmacokinetics of SY-007
Description
Peak Plasma Concentration (Cmax)
Time Frame
From Day 0 to Day 7
Title
Pharmacokinetics of SY-007
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
From Day 0 to Day 7
Title
Pharmacokinetics of SY-007
Description
Time to Cmax (Tmax)
Time Frame
From Day 0 to Day 7
Title
Pharmacokinetics of SY-007
Description
Terminal half life (T½)
Time Frame
From Day 0 to Day 7
Title
Pharmacokinetics of SY-007
Description
Clearance (CL)
Time Frame
From Day 0 to Day 7
Title
Pharmacokinetics of SY-007
Description
Volume of distribution
Time Frame
From Day 0 to Day 7
Title
Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90
Description
Excellent mRS is defined as mRS score of 0 or 1
Time Frame
Day 8, Day30, Day60, Day90
Title
Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
Description
Modified Rankin Scale Score range from 0 to 5，higher score mean a worse outcome.
Time Frame
Day 8, Day30, Day60, Day90
Title
Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30
Time Frame
Day 8, Day30
Title
Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30
Time Frame
Day 8, Day30
Title
Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90
Description
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.
Time Frame
Day 8, Day30, Day60, Day 90
Title
Change of Cerebral infarction volume before and after treatment
Time Frame
Baseline, Day 8, Day30
Title
Immunogenicity of SY-007
Description
Anti-Drug antibody evaluation
Time Frame
From Day 0 to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
Country
China

12. IPD Sharing Statement

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SY007 in Patients With Acute Ischemic Stroke

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