A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
研究概览
简要总结
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.
Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Male or female participants who are overtly healthy as determined by medical evaluation
- •Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
- •Contraceptive use by participants should be consistent with local regulations
排除标准
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Have known allergies to LY3209590, related compounds, or any components of the formulation
- •Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
- •Are lactating or pregnant
研究组 & 干预措施
LY3209590 (Formulation 1)
Single dose of LY3209590 as formulation 1 administered subcutaneously (SC).
干预措施: LY3209590 (Formulation 1) (Drug)
LY3209590 (Formulation 2)
Single dose of LY3209590 as formulation 2 administered SC.
干预措施: LY3209590 (Formulation 2) (Drug)
结局指标
主要结局
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
时间窗: Predose up to 65 days post dose
PK: AUC(0-∞) of LY3209590
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590
时间窗: Predose up to 65 days post dose
PK: AUC(0-tlast) of LY3209590
PK: Maximum Observed Concentration (Cmax) of LY3209590
时间窗: Predose up to 65 days post dose
PK: Cmax of LY3209590
次要结局
未报告次要终点