NCT07446101招募中1 期
An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.
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 females as determined by medical evaluation including:
- •medical history
- •physical examination
- •clinical laboratory tests
- •vital signs.
- •Have clinical laboratory test results at screening and Day -1 within normal reference range.
- •Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive.
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 significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs.
- •Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- •Are immunocompromised.
- •Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
- •Have received treatment with biologic agents within 3 months or 5 half-lives, whichever is longer, prior to dosing.
- •Have previously received mirikizumab.
- •Have an abnormality in the 12-lead electrocardiogram (ECG).
- •Have clinically significant abnormalities in blood pressure, pulse rate, or body temperature.
- •Have a current or recent acute, active infection.
- •Have active tuberculosis (TB), or any history of active TB.
研究组 & 干预措施
Mirikizumab (Test Arm 1)
Experimental
Mirikizumab administered subcutaneously (SC)
干预措施: Mirikizumab (Drug)
Mirikizumab (Test Arm 2)
Experimental
Mirikizumab administered SC
干预措施: Mirikizumab (Drug)
Mirikizumab (Reference Arm)
Experimental
Mirikizumab administered SC
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
时间窗: Day 1 through Day 71
PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828
时间窗: Day 1 through Day 71
次要结局
未报告次要终点
研究者
研究点 (5)
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