A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
研究概览
简要总结
The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.
Screening is required within 28 days prior to the 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
- 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
- •Are overtly healthy males or non-pregnant females of childbearing or non-childbearing potential
- •Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive)
排除标准
- •Must not show evidence of active or latent tuberculosis (TB)
- •Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
- •Must not have been treated with steroids within 1 month of screening, or intend to during the study
- •Must not have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1
- •Must not be immunocompromised
- •Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
- •Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
- •Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Must not have had breast cancer within the past 10 years
- •Must not have significant allergies to humanized monoclonal antibodies
研究组 & 干预措施
Mirikizumab - Prefilled Syringe
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs.
干预措施: Mirikizumab Prefilled Syringe (Drug)
Mirikizumab - Autoinjector
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs.
干预措施: Mirikizumab Autoinjector (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
时间窗: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
PK: Cmax of Mirikizumab administered by PFS and AI.
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI
时间窗: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI
时间窗: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.
次要结局
未报告次要终点