NCT03290560已完成2 期
A Randomized, Double-blind, Placebo-controlled Phase II Multi-Center Evaluation to Assess the Safety and Tolerability of DM199 Administered Intravenously and Subcutaneously in Subjects With Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 12
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
研究概览
简要总结
This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >/= 18 years of age
- •Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment.
- •Subject has NIH stroke score (NIHSS) ≥ 6 and ≤
- •Subject or legally authorized representative is willing and able to sign written informed consent.
排除标准
- •Subject is currently prescribed angiotensin-converting-enzyme inhibitors (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment during the active treatment period (+5 days) of the study.
- •Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
- •Subjects with current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least six months have elapsed since the procedure.
- •Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment.
- •Subject has clinical or laboratory evidence of an active infection at the time of enrollment.
- •Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
- •Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
- •Subject is pregnant or nursing.
- •Subject is male or female of childbearing potential, is participating in heterosexual sexual activity that could lead to pregnancy, and is unable or unwilling to practice medically effective contraception during the study.
- •Subject is participating in any other investigational device or other drug study ≤ 4 weeks or 5 half-lives of the investigational product, whichever is longer.
- •Subject does not have sufficient venous access for infusion of study treatment or blood sampling.
- •In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study.
- •Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- •Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
- •Pre-stroke Modified Rankin Scale ≥4
研究组 & 干预措施
Recombinant human tissue kallikrein
Experimental
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
干预措施: Recombinant human tissue kallikrein (Drug)
Placebo
Placebo Comparator
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
时间窗: 90 Days
Assessed by total number and severity of all treatment-related adverse events.
次要结局
- Changes from baseline to Day 90 of Modified Rankin Scale.(90 Days)
- Changes from baseline to Day 90 of NIH Stroke Scale.(90 Days)
- Changes from baseline to Day 90 of Barthel Index.(90 Days)
研究者
研究点 (12)
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