A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3532226 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 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 the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including 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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females not of childbearing potential.
- •Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive
排除标准
- •Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
- •Have a history of malignancy within 5 years prior to screening
- •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
- •Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X the upper limit of normal (ULN) or total bilirubin level (TBL) >1.5X ULN
- •Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)
- •Have undergone any form of bariatric surgery
- •Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening
研究组 & 干预措施
LY3532226
Single ascending doses of LY3532226 administered subcutaneously (SC).
干预措施: LY3532226 (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 up to Week 8
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): Maximum Concentration (Cmax) of LY3532226(Day 1 through Day 43)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226(Day 1 through Day 43)
- PK: Time to Maximum Concentration (Tmax) of LY3532226(Day 1 through Day 43)