NCT01925157已完成1 期
A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Number of Participants with One or More Adverse Event(s) 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 LY3090106 in healthy participants and in participants with RA who are having an inadequate response to methotrexate (MTX). The study will investigate how the body processes the study drug and how the study drug affects the body. The study will last about 3 months for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through 12 weeks
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106(Predose through 12 Weeks)
- Number of Participants with Anti-LY3090106 Antibodies(Baseline through 12 Weeks)
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106(Predose through 12 Weeks)
研究者
研究点 (5)
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