A Phase 1, Randomized, Placebo-controlled, Participant- and Investigator-blind, Single-dose Study of the Pharmacokinetics of LY3471851 Following Subcutaneous Dosing of LY3471851 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 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 purpose of this study is to compare two different formulations (test & reference) of LY3471851 in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving the study drug that is LY3471851.
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
- Double (Participant, Investigator)
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
- •Participants who are overtly healthy as determined by medical history and physical examination
- •Have body weight greater than 45 kilograms (kg) and body mass index within the range 18.0 to 32.0 kilograms per square meter (kg/m²)
- •Male and female participants must agree to adhere to contraceptive requirements
排除标准
- •Have an abnormality in the 12-lead electrocardiogram (ECG), vital signs, or both
- •Have had symptomatic herpes zoster within 3 months prior to screening
- •Have a known allergy or hypersensitivity to levocetirizine
- •Intend to use prescription or nonprescription medication within 14 days or 5 half-lives prior to dosing
- •Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
- •Smoke more than 10 cigarettes or other tobacco products per day before study entry
- •Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study
研究组 & 干预措施
LY3471851 (Test formulation)
LY3471851 administered subcutaneously (SC).
干预措施: LY3471851 (Drug)
LY3471851 (Test) + Levocetirizine
LY3471851 administered SC in combination with levocetirizine given orally.
干预措施: LY3471851 (Drug)
LY3471851 (Test) + Levocetirizine
LY3471851 administered SC in combination with levocetirizine given orally.
干预措施: Levocetirizine (Drug)
LY3471851 (Reference formulation)
LY3471851 administered SC.
干预措施: LY3471851 (Drug)
Placebo
Placebo administered SC.
干预措施: Placebo (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