NCT04998487已完成1 期
A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
研究概览
简要总结
The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females, as determined by medical history and physical examination.
- •Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)
排除标准
- •Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)
- •Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment
- •Are immunocompromised per investigator judgment.
研究组 & 干预措施
LY3471851 (Abdomen)
Experimental
LY3471851 administered subcutaneously (SC) into the abdomen.
干预措施: LY3471851 (Drug)
LY3471851 (Thigh)
Experimental
LY3471851 administered SC into the thigh.
干预措施: LY3471851 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
时间窗: Predose up to 56 days postdose
PK: Cmax of LY3471851
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851
时间窗: Predose up to 56 days postdose
PK: AUC of LY3471851
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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