A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 20
- 主要终点
- Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
研究概览
简要总结
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is an acute ischemic stroke patients with evidence of intracranial vascular occlusion
- •Is enrolled in principle within 8 hours of symptom onset
- •Has treatment plan that includes stent retriever
- •Has protocol-defined scores on several scales
排除标准
- •Has treatment plan that includes fibrinolysis or fibinolysis
- •Has identified intracranial hemorrhage or subarachnoid hemorrhage
- •Has active bleeding like gastrointestinal hemorrhage
- •Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
- •Has severe hepatic or renal impairment
- •Has been a participant in other clinical trial within 30 days prior to treatment
- •Is pregnant, lactating, or planning on becoming pregnant during treatment period
- •Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:
- •safety or well-being of the participant or their offspring
- •safety of the study staff
- •analysis of results
研究组 & 干预措施
DS-1040b 0.6 mg
Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours
干预措施: DS1040b (Drug)
DS-1040b 1.2 mg
Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours
干预措施: DS1040b (Drug)
DS-1040b 2.4 mg
Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours
干预措施: DS1040b (Drug)
DS-1040b 4.8 mg
Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours
干预措施: DS1040b (Drug)
Placebo
Participants receive saline by intravenous infusion over six hours
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
时间窗: From start of treatment up to 36 hours post single, intravenous dose
Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving \> 30% of, or outside the infarcted area, with a significant mass effect.
Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants
时间窗: From start of treatment up to 96 hours post single, intravenous dose
Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin.
次要结局
- Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma(Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose)
- Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants(Baseline, 6 hours and 24 hours post single, intravenous dose)
- Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma(Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose)
- Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma(Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose)
- Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants(From start of treatment up to 24 hours post single, intravenous dose)
- Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants(Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose)
- Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma(Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose)
- Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants(Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose)