A Study of LY3002815 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2018-09-26

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3002815

Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants

Group Type EXPERIMENTAL

LY3002815

Intervention Type DRUG

Administered IV

Placebo

Placebo administered IV once in healthy participants

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

Interventions

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LY3002815

Administered IV

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes