A Study of LY3002815 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3002815
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3002815<br>Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants | Drug: LY3002815<br>* Administered IV<br>|
| Placebo Comparator: Placebo<br>Placebo administered IV once in healthy participants | Drug: Placebo<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline through at least 85 days after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |