A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3025876 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 1 or More Drug-related Adverse Events or Any Serious Adverse Events
研究概览
简要总结
This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
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
- •Must be either a healthy male or a healthy female who cannot become pregnant
- •Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening
排除标准
- •Are allergic to LY3025876 or related compounds
- •Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
- •Have 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. Corticosteroids are mainly used to control inflammation.
研究组 & 干预措施
Placebo
0.9% sodium chloride given as a single subcutaneous injection
干预措施: Placebo (Drug)
LY3025876
Single escalating doses of LY3025876 given as subcutaneous injections
干预措施: LY3025876 (Drug)
结局指标
主要结局
Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events
时间窗: Baseline up to 28 days post-dose
Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose)
- Number of Participants Developing Anti-LY3025876 Antibodies(Day 28 post-dose)
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876(Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose)