NCT01783691已完成1 期
A Single Ascending Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of Intravenous NKTT120 in Adults With Stable Sickle Cell Disease
NKT Therapeutics6 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Safety as assessed by (1) adverse events (2) laboratory values (3) vital signs and (4) physical exam.
研究概览
简要总结
The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 50 years
- •Subject has a confirmed diagnosis of HbSS or HbSβ0thal
- •Subject has stable SCD defined as not having acute VOC, ACS, or other major SCD associated event during the month prior to enrollment
排除标准
- •Subject had an SCD-related VOC or ACS that required hospitalization or treatment in acute care outpatient setting in the month prior to enrollment
- •Subject requires a program of prescheduled regularly administered packed red blood cell (pRBC) transfusions or Subject received a pRBC transfusion in the month prior to enrollment
- •Subject has evidence of latent or active tuberculosis
- •Subject has a major concurrent illness or medical condition
- •Subject is pregnant or nursing
研究组 & 干预措施
NKTT120
Experimental
干预措施: NKTT120 (Drug)
结局指标
主要结局
Safety as assessed by (1) adverse events (2) laboratory values (3) vital signs and (4) physical exam.
时间窗: 180 days
次要结局
- Pharmacokinetics assessed by plasma drug concentration levels(0; 15, 30, 60 minutes; 3,6, hours; 1,2,3,7,14,30,60,90 days)
- Pharmacodynamics as measured by assessments of peripheral blood lymphocyte subsets(0, 0.25, 1, 2, 7, 14, 30, 60, 90, 120 days)
研究者
研究点 (6)
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