SY007 in Patients With Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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15mg SY-007/ Placebo Repeat Dose

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

Group Type EXPERIMENTAL

SY-007/ Placebo 15mg

Intervention Type DRUG

15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

30mg SY-007/ Placebo Repeat Dose

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

Group Type EXPERIMENTAL

SY-007/ Placebo 30mg

Intervention Type DRUG

30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

60mg SY-007/ Placebo Repeat Dose

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

Group Type EXPERIMENTAL

SY-007/ Placebo 60mg

Intervention Type DRUG

60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Interventions

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SY-007/ Placebo 15mg

15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Intervention Type DRUG

SY-007/ Placebo 30mg

30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Intervention Type DRUG

SY-007/ Placebo 60mg

60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No