A Phase 1, Open-Label, Single-Dose Bioequivalence Study of Injections of Lebrikizumab Using a 2-mL Pre-Filled Syringe With Needle Safety Device and an Investigational 2-mL Autoinjector in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab
研究概览
简要总结
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be evaluated. The study will last up to 102 days.
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 nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation.
- •Agree not to donate blood or plasma until after the end of their participation in the study
- •Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
排除标准
- •Are females who are pregnant or lactating.
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Have a history or presence of psychiatric disorders
- •Show evidence of human immunodeficiency virus infection.
- •Show evidence of hepatitis C and/or hepatitis B
- •Medical history of allergic reaction to humanized monoclonal antibodies
- •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.
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or are unable to abide by CRU smoking restrictions
研究组 & 干预措施
Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device
2-milliliter (mL) (125 milligrams per milliliter [mg/mL]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).
干预措施: Lebrikizumab (Drug)
Lebrikizumab (Test) - Autoinjector
2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
干预措施: Lebrikizumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab
时间窗: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: Cmax of Lebrikizumab
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab
时间窗: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: AUC\[0-∞\] of Lebrikizumab
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
时间窗: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: AUC\[0-tlast\] of Lebrikizumab
次要结局
未报告次要终点