EUCTR2015-001824-43-FR进行中（未招募）1 期
A Phase 1b/2, multi-center, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebo-controlled, randomized, single-ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.
Daiichi Sankyo Development Ltd0 个研究点目标入组 96 人开始时间: 2015年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects have a clinical diagnosis of ischemic stroke with middle cerebral artery (MCA) occlusion (M1 or M2), as demonstrated by computed tomography (CT) angiography or magnetic resonance (MR) angiography.
- •2. Men and women 18 to 80 years of age, inclusive.
- •3. Subjects have stroke symptom onset within 3 to 8 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptom onset time refers to the last time the subject was known to be well.
- •4. Subjects have a NIHSS score > 4 and < 22.
- •5. Subjects have a body weight of 50 kg to 120 kg, inclusive.
- •6. Subjects, or their legally authorized representative, must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1. Subjects have evidence of intracranial hemorrhage on non-contrast CT (or MR).
- •2. Subjects have symptoms of subarachnoid hemorrhage, even with normal CT.
- •3. Subjects have evidence of large MCA territory infarction (sulcal effacement or blurring of gray white junction in greater than 1/3 of MCA territory).
- •4. Subjects have prior non-traumatic intracranial hemorrhage.
- •5. Subjects have known arteriovenous malformation or aneurysm.
- •6. Subjects have evidence of active bleeding.
- •7. Subjects have platelet count < 100,000.
- •8. Subjects have International Normalized Ratio > 1.7.
- •9. Subjects have used heparin within 48 hours or have an elevated partial thromboplastin time.
- •10. Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours.
- •11. Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 48 hours.
- •12. Subjects with anticipated use of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization.
- •13. Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke.
- •14. Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit).
- •15. Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 3 months.
- •16. Subjects have had major surgery within 14 days.
- •17. Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days.
- •18. Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days.
- •19. Subjects have a preexisting disability classified by mRS > 1.
- •20. Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2.
- •21. Subjects have baseline haemoglobin < 10.5 g/dL.
- •22. Subjects have a positive pregnancy test. Serum pregnancy tests will be performed in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age).
- •23. Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half lives of that investigational drug prior to administration of the study drug.
- •24. Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (PAREXEL), or the Site.
- •25. Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
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