NCT04891913暂停1 期
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 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and tolerance of SY-007
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
15mg SY-007/ Placebo Repeat Dose
Experimental
Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days.
干预措施: SY-007/ Placebo 15mg (Drug)
30mg SY-007/ Placebo Repeat Dose
Experimental
Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days.
干预措施: SY-007/ Placebo 30mg (Drug)
60mg SY-007/ Placebo Repeat Dose
Experimental
Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.
干预措施: SY-007/ Placebo 60mg (Drug)
结局指标
主要结局
Safety and tolerance of SY-007
时间窗: From Day 0 to Day 90
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
次要结局
- 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)
研究者
研究点 (1)
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