jRCT2031210233进行中（未招募）不适用
A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-0616 in Healthy Japanese Participants.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MSD K.K.
- 入组人数
- 48
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- All
入选标准
- •Healthy male participants and female participants of nonchildbearing potential between the ages of 20 and 45 years
排除标准
- •Has a history of clinically significant abnormalities or diseases
结局指标
主要结局
Safety
AEs, physical examination findings, laboratory safety assessments, 12-lead ECG, vital signs
phaemacokinetics (Single Dose)
AUC0-inf, AUC0-24, AUClast, Cmax, Tmax, C24, apparent terminal t1/2, CL/F and Vz/F
phaemacokinetics (Multiple Dose)
AUC0-24, Cmax, Tmax, C24, apparent terminal t1/2 and accumulation ratio
次要结局
- Percentage of reduction of free PCSK9 from baseline
- Free PCSK9 concentration
- Percent reduction of LDL-C from baseline
- LDL-C concentration
研究者
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