A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 5
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
研究概览
简要总结
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution given via autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.
Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 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
- Single (Participant)
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
- •Participants who are overtly healthy as determined by medical evaluation
- •Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
- •are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).
排除标准
- •Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy
- •Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
- •Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
- •Are lactating or pregnant
研究组 & 干预措施
Mirikizumab (Reference)
200 milligram (mg) of mirikizumab as reference formulation [100 mg/milliliter (mL)], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.
干预措施: Mirikizumab (Drug)
Mirikizumab (Test)
200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
时间窗: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
PK: Cmax of mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
时间窗: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
PK: AUC\[0-∞\] of Mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab
时间窗: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
PK: AUC\[0-tlast\] of Mirikizumab was evaluated.
次要结局
未报告次要终点