NCT07202871已完成1 期
A Phase 1, 2-Part Study to Determine the Effect of Injection Site on the Relative Bioavailability of a Single Subcutaneous Dose of LY3537031 and to Evaluate the Pharmacokinetics of a Single Intravenous Dose of LY3537031 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
- 47
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031
研究概览
简要总结
The main purpose of this study is to find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. This study will also look at the safety and tolerability of LY3537031.
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
- 21 Years 至 70 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 body weight of at least 45 kg.
- •Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive
- •Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.
排除标准
- •Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- •Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds.
- •Have undergone any form of bariatric surgery.
- •Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed)
- •Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× Upper Limit of Normal (ULN).
- •Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, or any evidence for hepatic impairment.
- •Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.
研究组 & 干预措施
LY3537031 - Part A
Experimental
LY3537031 administered Subcutaneously (SC) in three different injection sites
干预措施: LY3537031 (Drug)
LY3537031 - Part B
Experimental
LY3537031 administered Intravenously (IV)
干预措施: LY3537031 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031
时间窗: Day 1 Predose up to Day 64
PK: Cmax of LY3537031
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031
时间窗: Day 1 Predose up to Day 64
PK: AUC of LY3537031
次要结局
未报告次要终点
研究者
研究点 (1)
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