JPRN-UMIN000007062已完成1 期
A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS) - A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •-Have a serious disorder in any systems or have a serious metabolic defect, so that the investigators decide to be unsuitable for participation in the trial. -Have hemoglobin A1c 6.1 (JDS value) or more. -Any observation of diseases/symptomes below; malignant neoplasm, intrathecal infection/mass, proliferative retinopathy, %VC less than 70% in spirogram -Have a history of intolerance to transplantation of medical devices -Have received an investigational drugs or devices within a month before onformed consent -Be unsuitable for participation in the trial for any reason, according to the investigators.
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