A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 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
This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy male or a female who cannot get pregnant
- •Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- •Have veins suitable for ease of blood sampling
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously completed or withdrawn from this study
- •Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
- •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 been treated with weight loss medications within 3 months of screening
研究组 & 干预措施
0.15 mg LY3493269 SC
Participants received 0.15 mg LY3493269 SC.
干预措施: LY3493269 - SC (Drug)
0.5 mg LY3493269 SC
Participants received 0.5 mg LY3493269 SC.
干预措施: LY3493269 - SC (Drug)
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
干预措施: LY3493269 - SC (Drug)
0.5 mg LY3493269 IV
Participants received 0.5 mg LY3493269 intravenously (IV).
干预措施: LY3493269 - IV (Drug)
Placebo - SC
Participants received Placebo subcutaneously (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: Baseline through final follow-up (Up To 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 Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269(Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination)
- PK: Maximum Concentration (Cmax) of LY3493269(Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination)
- PK: Time to Maximum Concentration (Tmax) of LY3493269(Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination)