NCT01947933已完成1 期
A Phase I, Randomized, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Number of Participants With One or More Adverse Event(s) (AEs) 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 mirikizumab. The study will investigate how the body processes the study drug and how the 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
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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) (AEs) Considered by the Investigator to Be Related to Study Drug Administration
时间窗: Baseline through Week 12
This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828(IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85)
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828(IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
A Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseCrohn's DiseaseNCT03926130Eli Lilly and Company1,158
已完成
3 期
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial CancerUrothelial CarcinomaNCT02426125Eli Lilly and Company530
已完成
1 期
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT02222688Thomas Kipps26
已完成
1 期
Phase I Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2256098 in Healthy VolunteersCancerNCT00996671GlaxoSmithKline38
已完成
2 期
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's DiseaseCrohn's DiseaseNCT02891226Eli Lilly and Company191