A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 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 evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have normal blood pressure
- •Must be a healthy male or female who cannot become pregnant
- •Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening
排除标准
- •Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds
- •Have previous exposure to FGF21 analogues or GLP1 analogues
- •Have received live vaccine(s) within 1 month of screening, or intend to during the study
- •Have previously completed or withdrawn from this study
- •Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of the study
- •Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- •Have problems with the immune system, due to a disease or treatment
- •Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2
- •Have a history of pancreatitis
研究组 & 干预措施
Placebo
Single dose of placebo matching LY3084077 administered subcutaneously (SC).
干预措施: Placebo (Drug)
LY3084077
Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.
干预措施: LY3084077 (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: Pre-dose, Up to Day 190
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. 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
- PD: Change From Baseline in Weight(Baseline, Up to Day 15)
- PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077(Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose)
- PD: Change From Baseline in Fasting Insulin(Baseline, Up to Day 15)
- Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides(Baseline, Up to Day 15)
- PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal(Baseline, Day 2)
- PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal(Baseline, Day 2)
- PD: Change From Baseline to Day 2 in Fasting Glucagon(Baseline, Up to Day 2)
- Number of Participants Developing Anti-LY3084077 Antibodies(Pre-dose, Up to Day 190)
- Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077(Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose)