SY007 in Patients With Acute Ischemic Stroke

Yabao Pharmaceutical Group

Status and phase: Suspended; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: SY-007/ Placebo 60mg; Drug: SY-007/ Placebo 15mg; Drug: SY-007/ Placebo 30mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04891913

SY007002

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

15mg SY-007/ Placebo Repeat Dose

Experimental group

Description:

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

Treatment:

Drug: SY-007/ Placebo 15mg

30mg SY-007/ Placebo Repeat Dose

Experimental group

Description:

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

Treatment:

Drug: SY-007/ Placebo 30mg

60mg SY-007/ Placebo Repeat Dose

Experimental group

Description:

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

Treatment:

Drug: SY-007/ Placebo 60mg