A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 45
- 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 purposes of this study are to determine:
- The safety of the study drug and any side effects that might be associated with it.
- How much of the study drug gets into the blood stream and how long it takes the body to remove it in healthy participants.
Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.
This study involves a single dose of LY3002815 or placebo given as an injection into the vein. This study will last approximately 16 weeks including screening. Additional follow-up may be required.
This study is for research purposes only, and is not intended to treat any medical condition.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination. Males will be required to use reliable method of birth control. Females have to be of non-child-bearing potential
- •Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at screening
排除标准
- •Have family history of early onset Alzheimer's Disease (AD)
- •Have impaired cognitive function
- •Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- •Have significant allergic reactions to LY3002815, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- •Women who are lactating
- •Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
研究组 & 干预措施
LY3002815
Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants
干预措施: LY3002815 (Drug)
Placebo
Placebo administered IV once in healthy participants
干预措施: Placebo (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 at least 85 days after administration of study drug
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3002815(Baseline through at least 85 days after administration of study drug)
- Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3002815(Baseline through at least 85 days after administration of study drug)