A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects
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 Adverse Events (AEs) or Any Serious AEs
研究概览
简要总结
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).
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
- •Normal blood pressure
- •Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
- •Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening
排除标准
- •Had known allergies to LY3053102 or related compounds
- •Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
- •Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
- •Heavy smokers (more than 10 cigarettes a day)
研究组 & 干预措施
LY3053102
A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.
干预措施: LY3053102 (Drug)
Placebo
A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs
时间窗: Baseline through Day 31
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102(Time 0 to 168 hours after study drug administration on Day 1)
- PK: Observed Maximum Drug Concentration (Cmax) of LY3053102(Time 0 to 168 hours after study drug administration on Day 1)
- Number of Participants Who Developed Anti-LY3053102 Antibodies(Baseline, up to Day 31)