A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 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 study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Are investigator site personnel directly affiliated with this study and their immediate families
- •Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
- •Have participated, within the last 3 months, in a clinical trial
- •Have known or ongoing psychiatric disorders
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •History of/current phaeochromocytoma
- •History of/current insulinoma
研究组 & 干预措施
LY3143753 (Part A)
Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1
干预措施: LY3143753 (Part A) (Drug)
LY3185643 (Part B)
Single SC injection of ascending doses of LY3185643 on Day 1
干预措施: LY3185643 (Part B) (Drug)
Placebo (Part A)
Single SC injection of normal saline on Day 1
干预措施: Placebo (Part A and Part B) (Drug)
rGlucagon (Part B)
Single SC injection on Day 1
干预措施: rGlucagon (Part B) (Drug)
Placebo (Part B)
Single SC injection of normal saline on Day 1
干预措施: Placebo (Part A and Part B) (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 to Study Completion (Up to 84 Days)
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
次要结局
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- PK: Cmax of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- PK: AUC(0-∞) of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- PK: Time to Maximum Drug Concentration (Tmax) of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- PK: Tmax of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours)
- Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- PD Absolute Maximum Blood Glucose of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- PD: Maximum Glucose Increase (Gmax) of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- PD: Gmax of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- PD: Time to Maximum Blood Glucose (Gtmax) of Part A(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- PD: Gtmax of Part B(Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours)
- QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A(Baseline, 8 hours after drug administration)
- QTcF Change From Baseline of Part B(Baseline, 8 hours after drug administration)