NCT01952548已完成1 期
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Adverse Events
研究概览
简要总结
This study will test single doses of the study drug in increasing amounts to see if it is safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent before any study-specific evaluation is performed.
- •Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
- •Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.
排除标准
- •Subject is a woman who is of childbearing potential or is breastfeeding.
- •Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
研究组 & 干预措施
Dose 3 Active
Experimental
干预措施: K-312 (Drug)
Dose 3 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 1 Active
Experimental
干预措施: K-312 (Drug)
Dose 2 Active
Experimental
干预措施: K-312 (Drug)
Dose 4 Active
Experimental
干预措施: K-312 (Drug)
Dose 5 Active
Experimental
干预措施: K-312 (Drug)
Dose 6 Active
Experimental
干预措施: K-312 (Drug)
Dose 7 Active
Experimental
干预措施: K-312 (Drug)
Dose 1 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 2 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 4 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 5 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 6 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 7 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: 10 Days
次要结局
未报告次要终点
研究者
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