A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.
The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.
Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.
This study has 3 parts:
- Participants in Part A will complete 1 study period (approximately 1 week).
- Participants in Part B will complete 3 study periods (approximately 3 weeks).
- Participants in Part C will complete 2 study periods (approximately 2 weeks).
详细描述
Parts B and C added per protocol amendment, approved in April 2019.
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)
盲法说明
Double-blind in Part A. Open label in Parts B and C.
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
- •Healthy male or a female who cannot become pregnant
- •Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²)
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- •Have veins suitable for easy blood collection and glucose solution infusion
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months
- •Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
- •Smoke more than 10 cigarettes per day
- •Are infected with hepatitis B or human immunodeficiency virus (HIV)
- •Have a history of allergies or reactions to more than one drug, or significant severe drug allergy
- •Are taking illegal drugs
研究组 & 干预措施
Insulin Degludec - IV (Part C)
Single IV dose of insulin degludec in one of two study periods
干预措施: Insulin Degludec - IV (Drug)
LY3374849 - SC (Part A)
Single subcutaneous (SC) dose of LY3374849
干预措施: LY3374849 - SC (Drug)
Insulin Degludec - SC (Part A)
Single SC dose of insulin degludec
干预措施: Insulin Degludec - SC (Drug)
LY3374849 - SC (Part B)
Single dose of LY3374849 administered SC in up to three of three study periods
干预措施: LY3374849 - SC (Drug)
LY3374849 - IV (Part B)
Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods
干预措施: LY3374849 - IV (Drug)
LY3374849 - IV (Part C)
Single IV dose of LY3374849 in one of two study periods
干预措施: LY3374849 - IV (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to study completion (estimated at 11 weeks)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849(Baseline at predose through 6 days post-dose for each study arm)
- Glucodynamics: Total Amount of Glucose Infused (Gtot)(Baseline up to 36 hours post-dose for each study arm)