A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
研究概览
简要总结
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
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
- None
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
- •Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
- •Have medical test results that are acceptable for the study
- •Must be willing to make oneself available for the whole study and be willing to follow study procedures
排除标准
- •Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- •Have known allergies to compounds or drugs similar to Mirikizumab
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
研究组 & 干预措施
Mirikizumab Reference
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants
干预措施: Mirikizumab Reference (Biological)
Mirikizumab Test Subcutaneous (SC) 1
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
干预措施: Mirikizumab Test (Biological)
Mirikizumab Test SC 2
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
干预措施: Mirikizumab Test (Biological)
Mirikizumab Test Intravenous (IV)
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
干预措施: Mirikizumab Test (Biological)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
时间窗: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab
次要结局
- PK: Maximum Observed Concentration (Cmax) of Mirikizumab(0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose)
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab(0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose)