A Phase 1, Randomized, Investigator- and Participant-Blind, Placebo-Controlled Study of LY3473329 Multiple-Ascending Dosing in Healthy Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined through medical history and physical examination.
- •Are males who agree to follow contraception requirements or females not of childbearing potential.
- •Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
排除标准
- •Have a history or presence of medical illness.
- •Have significant history of or current psychiatric disorders.
- •Have abnormalities in the 12-lead ECG and blood pressure.
- •Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) [Lp(a)].
研究组 & 干预措施
LY3473329
LY3473329 administered orally.
干预措施: LY3473329 (Drug)
Placebo
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 43
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329(Predose on Day 1 through Day 43)
- PK: Maximum Concentration (Cmax) of LY3473329(Predose on Day 1 through Day 43)
- PK: Time to Maximum Concentration (Tmax) of LY3473329(Predose on Day 1 through Day 43)