A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 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 purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination
- •Women not of childbearing potential
- •Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening
排除标准
- •Have clinically significant abnormal electrocardiogram (ECG) results
- •Have persistent abnormal blood pressure or pulse rate, as determined by the investigator
- •Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg) or ≥10 mmHg, respectively
- •Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders
- •Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy
- •Have significant allergies to humanized monoclonal antibodies
研究组 & 干预措施
10 milligram (mg) LY3478006 - Intravenous (IV)
Participants received single dose of 10 mg LY3478006 administered IV. Due to early termination of the study Cohort 2 to 6 (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg LY3478006 IV) were not explored for safety reasons following dosing of the first 4 participants in Cohort 1.
干预措施: LY3478006 - IV (Drug)
Placebo - IV
Participants received single dose of placebo administered IV. Placebo IV Cohorts 2 through 6 were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.
干预措施: Placebo - IV (Drug)
100 mg LY3478006 - Subcutaneous (SC) (Cohort 7)
100 mg LY3478006 cohort 7 SC dose was not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.
干预措施: LY3478006 - SC (Drug)
Placebo - SC (Cohort 7)
Placebo cohort 7 SC dose were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.
干预措施: Placebo - SC (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 109 days)
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006(Predose; Day 1 with end of infusion, 3, 6, 12 hours)
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006(Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85)