A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3537031 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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
The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.
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 male or female not of childbearing potential
- •Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)
- •Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- •Have veins suitable for blood sampling
排除标准
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Have a diagnosis or history of cancer or malignant disease within 5 years
- •Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening
- •Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
- •Have undergone any form of bariatric surgery
- •Have previously completed or withdrawn from this study
- •Are currently participating in or completed a clinical trial within the last 3 months
- •Regularly use known drugs of abuse or with positive drug results
- •Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission
研究组 & 干预措施
LY3537031
LY3537031 administered subcutaneously (SC).
干预措施: LY3537031 (Drug)
Placebo
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 through final follow-up at approximately Day 43
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
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031(Baseline through final follow-up at approximately Day 43)
- PK: Maximum Concentration (Cmax) of LY3537031(Baseline through final follow-up at approximately Day 43)