A Study of LY3002815 in Healthy Participants

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Lilly

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: LY3002815

Study type

Interventional

Funder types

Industry

Identifiers

NCT03148431
2016-004453-33 (EudraCT Number)
I9G-MC-CCBA (Other Identifier)
16529

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 2 patient groups, including a placebo group

LY3002815
Experimental group
Description:
Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants
Treatment:
Drug: LY3002815
Placebo
Placebo Comparator group
Description:
Placebo administered IV once in healthy participants
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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