A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese 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 purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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 native Chinese participants
- •Are overtly healthy
- •Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive
- •Have a stable body weight within 3 months
排除标准
- •Have known allergies to any components of the LY3985863 formulation
- •Have concomitant disease known to influence skeletal muscle protein
- •Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data
- •Have a 12-lead echocardiogram (ECG) abnormality
- •Have used within 3 months or intend to use medications during the study that promote weight loss
研究组 & 干预措施
LY3985863
Administered subcutaneously (SC)
干预措施: LY3985863 (Drug)
Placebo
Administered SC
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 to Study Completion (Up to 19 Weeks)
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863(Predose on Day 1 up to Approximately Week 8 Post Dose)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863(Predose on Day 1 up to Approximately Week 8 Post Dose)