A Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 Administered Subcutaneously to Japanese and Caucasian Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 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 main purpose of this study is to evaluate the safety of the study drug known as LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body processes the drug and how the drug affects the body. The study is expected to last about 5 to 7 months, depending on the arm.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are either Caucasian or first generation Japanese.
- •Participants' body mass index (BMI) is between 18.0 and 35.0 kilogram per meter square (kg/ m^2).
排除标准
- •Participants are heavy caffeine drinkers defined by regular intake of more than 5 cups of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable or unwilling to abide by caffeine restrictions as specified in the protocol.
- •Participants are smoking within the previous 6 months.
- •Participants have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or have received a vaccination within 1 month.
- •Participants have known allergies to LY2951742, related compounds or any components of the formulation, or history of significant atopy.
- •Participants are allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.
研究组 & 干预措施
5 mg LY2951742 Single Dose
5 mg LY2951742 given subcutaneously once
干预措施: LY2951742 (Drug)
50 mg LY2951742 Single Dose
50 mg LY2951742 given subcutaneously once
干预措施: LY2951742 (Drug)
120 mg LY2951742 Single Dose
120 mg LY2951742 given subcutaneously once
干预措施: LY2951742 (Drug)
300 mg LY2951742 Single Dose
300 mg LY2951742 given subcutaneously once
干预措施: LY2951742 (Drug)
300 mg LY2951742 Multiple Dose
300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
干预措施: LY2951742 (Drug)
Placebo Single Dose
Placebo given subcutaneously once
干预措施: Placebo (Drug)
Placebo Multiple Dose
Placebo given subcutaneously once every 4 weeks (Q4W)
干预措施: Placebo (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 197
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742(Day 1: Predose, 8 hr and 24 hour postdose)
- Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])(Day 1: Predose, 8 hr and 24 hour postdose)