A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 35
- 主要终点
- Symptomatic Intracranial Hemorrhage (sICH)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.
Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.
详细描述
This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 180 participants will be randomized to receive a single dose of two sequential dose levels of study drug or placebo.
All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study as outlined in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke
- •18 years or older
- •Anterior circulation intra-cranial occlusion
- •NIHSS score >3
- •Onset of stroke symptoms within 24 hours of enrollment
排除标准
- •Large volume ischemic stroke
- •Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
- •Chronic intracranial occlusion
- •Weight >125kg
- •Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
- •Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
- •Prior stroke within 90 days
- •Unable to undergo a contrast brain perfusion scan with either MRI or CT
研究组 & 干预措施
Placebo
A single dose of matching placebo will be administered via IV bolus injection
干预措施: Placebo (Drug)
BB-031
A single dose of BB-031 will be administered via IV bolus injection
干预措施: BB-031 (Drug)
结局指标
主要结局
Symptomatic Intracranial Hemorrhage (sICH)
时间窗: 24 hours
Proportion of participants having a sICH
次要结局
- Adverse Events (AEs)(24 hours)
- Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)(24 hours)