A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
研究概览
简要总结
The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.
详细描述
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.
Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.
The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
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
- •Are a healthy male or a female who cannot become pregnant
- •Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at screening
- •Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study
- •Have veins suitable for easy blood collection
- •Are reliable and willing to be available for the whole study and be willing to follow study procedures
- •Have given consent to participate in this study
排除标准
- •Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days
- •Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study
- •Have received live vaccine(s) within 1 month of screening, or intend to during 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 a weakened immune system
- •Have previously completed or withdrawn from this study
- •Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study
- •Have electrocardiogram (ECG) readings that are not suitable for the study
- •Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study
- •Have a history of drug or alcohol abuse
- •Are infected with hepatitis B
- •Are infected with human immunodeficiency virus (HIV)
- •Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month
- •Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period
- •Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic
- •Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit
- •Are deemed unsuitable to participate by the study doctor for any other reasons
研究组 & 干预措施
1 mg LY3009385
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
0.3 mg LY3009385
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
3 mg LY3009385
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
9 mg LY3009385
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
22 mg LY3009385
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
54 mg LY3009385
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
干预措施: LY3009385 (Drug)
Placebo
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
时间窗: Baseline through Day 28
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385(Predose through Day 28)
- Pharmacokinetics: Maximum Concentration (Cmax)(Predose through Day 28)
- Change in Level of Blood Glucose Before and After a Standard Meal(Baseline, Day 5, and Day 14)
- Change in Level of C-peptide Before and After a Standard Meal(Baseline, Day 5, and Day 14)
- Change in Level of Glucagon Before and After a Standard Meal(Baseline, Day 14)
- Number of Participants Forming Antibody to LY3009385(Baseline through Day 28)