NCT07787182尚未招募1 期
A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 68
- 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 see how safe LY4405094 is and to see how much and how quickly LY4405094 gets into the bloodstream. For healthy participants, the study also looks at how much LY4405094 gets into the fluid around the brain and lasts up to 13 weeks and will include a 4-day stay in the Clinical Research Unit (CRU). For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 25 weeks and will include a 3-day stay in the CRU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study.
排除标准
- •Have known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY
- •Have known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.
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 25 Weeks
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants(Baseline through Study Completion (Week 13))
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)(Baseline through Study Completion (25 Weeks))
- Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants(Baseline through Study Completion (Week 13))
- Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD(Baseline through Study Completion (25 Weeks))
研究者
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