A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 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 in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are healthy males, or females of non-child-bearing potential
- •Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
- •Have clinical laboratory tests within normal ranges as judged by investigator
- •Have pulse rate and blood pressure within normal ranges as judged by investigator
排除标准
- •Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
- •Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
- •Regularly use known drugs of abuse
- •Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
- •Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
- •Smoke more than 10 cigarettes per day
- •Are current or former smokers with 30-pack-year smoking history
- •Have a diagnosis or history of any malignancy
- •Have not had appropriate cancer screening, in accordance with country specific guidance
研究组 & 干预措施
LY3461767 - Subcutaneous (SC)
LY3461767 administered SC.
干预措施: LY3461767 - SC (Drug)
Placebo - SC
Placebo administered SC.
干预措施: Placebo - SC (Drug)
LY3461767 - Intravenous (IV)
LY3461767 administered IV.
干预措施: LY3461767 - IV (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 Day 29
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 LY3461767(Baseline through Day 29)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767(Baseline through Day 29)