A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
研究概览
简要总结
The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation
- •Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.
- •Females of childbearing potential will be excluded from the study.
排除标准
- •Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- •Have a history within the past 5 years of a primary or recurrent malignant disease
- •Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing
- •Are pregnant or intend to become pregnant or to breastfeed during the study
- •Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions
- •Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome
研究组 & 干预措施
Donanemab
Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
干预措施: Donanemab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
时间窗: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71
As per the prespecified analysis, AUC\[0-4 weeks\] will be calculated as the sum of AUC0-2weeks for: * treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2 * treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4 * treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.
PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab
时间窗: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
PK: Cmax, ss of Donanemab
PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab
时间窗: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
PK: AUCτ,ss of Donanemab
次要结局
未报告次要终点