Healthy
Conditions
Brief summary
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.
Interventions
DRUGLY3002815
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed