A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3375880 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 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 purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.
This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.
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
- 18 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 males or females, as determined by medical history and physical examination
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- •Are women who are of childbearing potential or who are lactating
研究组 & 干预措施
LY3375880 Single Dose
Single dose of LY3375880 administered IV or SC
干预措施: LY3375880 IV (Drug)
LY3375880 Single Dose
Single dose of LY3375880 administered IV or SC
干预措施: LY3375880 SC (Drug)
Placebo Single Dose
Single dose of placebo administered IV or SC
干预措施: Placebo IV (Drug)
Placebo Single Dose
Single dose of placebo administered IV or SC
干预措施: Placebo SC (Drug)
LY3375880 Multiple Dose
Multiple doses of LY3375880 administered IV or SC
干预措施: LY3375880 IV (Drug)
LY3375880 Multiple Dose
Multiple doses of LY3375880 administered IV or SC
干预措施: LY3375880 SC (Drug)
Placebo Multiple Dose
Multiple doses of placebo administered IV or SC
干预措施: Placebo IV (Drug)
Placebo Multiple Dose
Multiple doses of placebo administered IV or SC
干预措施: Placebo SC (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: Pre-dose to 3 months after administration of study drug
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 Observed Drug Concentration (Cmax) of LY3375880(Pre-dose to 3 months after administration of study drug)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880(Pre-dose to 3 months after administration of study drug)