SY007 in Patients With Acute Ischemic Stroke

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

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.

Study Overview

• Status: Suspended
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: SY-007/ Placebo 15mg; Drug: SY-007/ Placebo 30mg; Drug: SY-007/ Placebo 60mg

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15mg SY-007/ Placebo Repeat Dose; Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days.	Drug: SY-007/ Placebo 15mg; 15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Experimental: 30mg SY-007/ Placebo Repeat Dose; Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days.	Drug: SY-007/ Placebo 30mg; 30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Experimental: 60mg SY-007/ Placebo Repeat Dose; Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.	Drug: SY-007/ Placebo 60mg; 60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerance of SY-007	Number of patients with treatment-emergent adverse events and number of patients who died over 90 days	From Day 0 to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of SY-007	Peak Plasma Concentration (Cmax)	From Day 0 to Day 7
Pharmacokinetics of SY-007	Area under the plasma concentration versus time curve (AUC)	From Day 0 to Day 7
Pharmacokinetics of SY-007	Time to Cmax (Tmax)	From Day 0 to Day 7
Pharmacokinetics of SY-007	Terminal half life (T½)	From Day 0 to Day 7
Pharmacokinetics of SY-007	Clearance (CL)	From Day 0 to Day 7
Pharmacokinetics of SY-007	Volume of distribution	From Day 0 to Day 7
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	Day 8, Day30, Day60, Day90
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.	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 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 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.	Day 8, Day30, Day60, Day 90
Change of Cerebral infarction volume before and after treatment		Baseline, Day 8, Day30
Immunogenicity of SY-007	Anti-Drug antibody evaluation	From Day 0 to Day 30

Collaborators and Investigators

• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 25, 2023
• Study Completion (Anticipated): December 25, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: SY007002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No