A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3819469
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) [Lp(a)] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants must not be able to get pregnant and male participants must agree to adhere to contraception restrictions
- •Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
- •For Part B, participants should be of first-generation Japanese origin
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days
- •Are heavy alcohol drinkers or heavy cigarette smokers
- •Have donated blood of more than 500 milliliters (mL) in the last 3 months
研究组 & 干预措施
LY3819469 (Part A)
Single ascending doses of LY3819469 administered subcutaneously (SC).
干预措施: LY3819469 (Drug)
LY3819469 (Part B)
Single doses of LY3819469 administered SC in Japanese Participants.
干预措施: LY3819469 (Drug)
Placebo (Part A)
Placebo administered SC.
干预措施: Placebo (Drug)
Placebo (Part B)
Placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Week 49
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)(Baseline up to Week 49)
- PK: Maximum Observed Drug Concentration (Cmax) of LY3819469(Predose through Day 15)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469(Predose through Day 15)