NCT02524678已完成1 期
A Phase I, Placebo-controlled, Randomized, Double Blind, Dose-escalation Study to Assess the Safety and Pharmacokinetic and Pharmacodynamic Characteristics of Repeated-dose URC102 in Healthy Korean Adult Males
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年8月5日最近更新:
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
- 1
- 主要终点
- Number of participants with AE
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in healthy subjects.
详细描述
Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response of blood and urinary uric acid levels will be assessed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
排除标准
- •Participated in other clinical study within past 3 months prior to receiving an IP administration
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
URC102
Active Comparator
URC102
干预措施: URC102 (Drug)
结局指标
主要结局
Number of participants with AE
时间窗: 2 week
次要结局
- Plasma URC102 concentration(2 week)
- Change of plasma uric acid(2 week)
研究者
研究点 (1)
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