A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
研究概览
简要总结
This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
详细描述
This is a multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS. The study is planned to take place in multiple countries. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 18 to 90 years.
- •Subject has an NIHSS of 6 to
- •Subject is able to receive the first IP within 24 hours after stroke symptoms onset.
- •Neuroimaging Inclusion Criteria:
- •Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
- •Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL.
排除标准
- •Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
- •Subject has a pre-stroke disability (mRS ≥2).
- •Subject has large ischemic core volume >70 mL or ASPECTS ≤
- •Subject has symptoms of suspected subarachnoid hemorrhage.
- •Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
- •Subject has significant mass effect with midline shift.
- •Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
- •Subject has current uncontrolled hypertension despite treatment.
- •Subject has INR >1.7 or abnormal aPTT or platelet count <100,000/mm^
- •Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
- •Subject has blood glucose concentration <50 mg/dL or >400 mg/dL.
- •Subject has moderate or severe hepatic, renal, and/or active infectious disease.
- •Subject is lactating, pregnant, or planning to become pregnant during the study.
- •Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening.
- •Subject has had any major surgery within 90 days before Screening.
- •Subject has had a bleeding event within 21 days before Screening.
- •Subject has puncture of noncompressible vessels within 7 days before Screening.
- •Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer).
- •In the opinion of the Investigator, the subject is not appropriate for the study.
研究组 & 干预措施
LT3001 Drug Product
Administered by intravenous infusion
干预措施: LT3001 Drug Product (Drug)
Placebo
Administered by intravenous infusion
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
时间窗: within 90 days after the first IP administration
There were no subjects in either treatment group who met the predefined criteria for the primary safety endpoint: the proportion of subjects with TEAEs judged to be probably or definitely related to the IP within 90 days after the first IP administration.
次要结局
未报告次要终点