A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 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 main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive
排除标准
- •Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
- •Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
- •Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
研究组 & 干预措施
LY3192767 (Part A)
Escalating doses of LY3192767 administered subcutaneously (SC).
干预措施: LY3192767 (Drug)
Placebo (Part A)
Placebo matching LY3192767 administered subcutaneously (SC).
干预措施: Placebo (Drug)
LY3192767 (Part B)
LY3192767 administered as a SC injection in one of three study periods.
干预措施: LY3192767 (Drug)
Basal Insulin Peglispro (Part B)
Basal insulin peglispro administered as a SC injection in one of three study periods.
干预措施: Basal Insulin Peglispro (Drug)
Insulin Glargine (Part B)
Insulin glargine administered as a SC injection in one of three study periods.
干预措施: Insulin Glargine (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 through Study Completion (up to about Day 49)
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
- PK: Maximum Serum Concentration (Cmax) of LY3192767(Predose through 336 Hours)
- PD: Change from Baseline in Free Fatty Acids(Predose through 48 Hours Postdose)
- PD: Change from Baseline in Glycerol(Predose through 48 Hours Postdose)
- Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767(Predose through 336 Hours)
- PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767(Predose through 336 Hours)
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767(Predose through 36 Hours During Clamp Procedure)
- PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767(Predose through 36 Hours During Clamp Procedure)
- PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767(Predose through 36 Hours During Clamp Procedure)
- PD: Change from Baseline in Triglycerides(Predose through 48 Hours Postdose)