A Study of LY3002815 in Healthy Participants

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: LY3002815; Drug: Placebo

• Registration Number: NCT03148431
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-05-24
• Primary Completion: 2017-12-15
• Study Completion: 2018-09-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3002815	LY3002815	Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants
Placebo	Placebo	Placebo administered IV once in healthy participants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇬🇧 Leeds, UK, United Kingdom