A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 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
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.
The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
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
- •At the time of initial screening, in general good health
- •First-generation healthy Japanese (age 20 to 65 years) will be included
排除标准
- •Pregnancy or breastfeeding during the study
- •Chronic infection
- •Treatment with prohibited medications
研究组 & 干预措施
LY3200327 (IV)
Single intravenous (IV) dose of LY3200327
干预措施: LY3200327 (IV) (Drug)
Placebo (SC)
Single subcutaneous (SC) dose of placebo
干预措施: Placebo (SC) (Drug)
LY3200327 (SC)
Single escalating subcutaneous (SC) dose of LY3200327
干预措施: LY3200327 (SC) (Drug)
Placebo (IV)
Single intravenous (IV) dose of placebo
干预措施: Placebo (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 to study completion (approximately 12 weeks)
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327(Pre-dose up to 84 days post dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327(Pre-dose up to 84 days post dose)