Relative Bioavailability of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
研究概览
简要总结
The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male participant or female participant who agree to not become pregnant
- •Are male participant or female participants with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study
排除标准
- •Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
- •Are allergic or hypersensitive to the study medicine
- •Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
- •Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
- •Show evidence of active or latent tuberculosis (TB)
- •Presence of significant neuropsychiatric disorder or a recent history of depression
- •Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant, if participating in the study
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
时间窗: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab.
时间窗: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
时间窗: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.
次要结局
未报告次要终点