A Phase 1, Open-Label, Single Dose Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Formulations of Eltrekibart in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
研究概览
简要总结
The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants.
The study will last about 17 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 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 as determined by medical evaluation including medical history and physical examination
- •Have a minimum body weight of 45 kilograms (kg).
- •Have a body mass index (BMI) within the range of 18.5 to 28.5 kilograms per square meter (kg/m²), inclusive
排除标准
- •Have multiple severe allergies to prescription or nonprescription drugs
- •Are immunocompromised
- •Have had any of the following types of infection within 3 months prior to the screening visit:
- •Serious, that is, requiring hospitalization, or intravenous or equivalent oral antibiotic treatment
- •Opportunistic infections Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
- •Chronic, that is, duration of symptoms, signs, or treatment of 6 weeks or longer, or
- •Recurring, including, but not limited to:
- •herpes simplex,
- •herpes zoster,
- •recurring cellulitis, or
- •chronic osteomyelitis.
- •Are currently pregnant or are intending to become pregnant or to breastfeed at any time in the study or within 16 weeks after receiving the single dose of study intervention.
研究组 & 干预措施
Eltrekibart Cohort 4
Eltrekibart administered SC
干预措施: LY3041658 (Drug)
Eltrekibart Cohort 3
Eltrekibart administered intravenously (IV)
干预措施: LY3041658 (Drug)
Eltrekibart Cohort 1
Eltrekibart administered subcutaneously (SC)
干预措施: LY3041658 (Drug)
Eltrekibart Cohort 2
Eltrekibart administered SC
干预措施: LY3041658 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
时间窗: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658
时间窗: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658
时间窗: Predose on Day 1 up to Day 85
次要结局
未报告次要终点