A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 10
- 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 LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.
The study has two parts:
- Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;
- Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.
详细描述
In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- •Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- •Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
- •Have family history of early onset Alzheimer's Disease (AD)
- •Have impaired cognitive function
- •History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
- •Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
- •Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
- •Have current serious or unstable illnesses
研究组 & 干预措施
Placebo (Part B)
Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.
干预措施: Placebo (Drug)
LY3372993 (Part A)
LY3372993 administered intravenously (IV) to healthy participants.
干预措施: LY3372993 (Drug)
Placebo (Part A)
Placebo administered IV to healthy participants.
干预措施: Placebo (Drug)
LY3372993 (Part B)
LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.
干预措施: LY3372993 (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 up to Day 562
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Cmax of LY3372993 at Steady State After Multiple Doses(Week 14 through Week 18)
- Pharmacodynamics (PD): Change from Baseline in Amyloid Load(Baseline, Week 28)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose(Predose up to Day 85)
- PK: AUC of LY3372993 at Steady State after Multiple Doses(Week 14 through Week 18)
- PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose(Predose up to Day 85)