A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-25

Study Completion Date

2018-07-10

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin.

Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments.

This is the first time that this study drug is being given to participants. 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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Alzheimer's Disease

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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LY3303560

Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.

Group Type EXPERIMENTAL

LY3303560 - IV

Intervention Type DRUG

Administered IV

Saline Solution

Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.

Group Type PLACEBO_COMPARATOR

Saline Solution - IV

Intervention Type DRUG

Administered IV

LY3303560 Subcutaneous (SC)

Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.

Group Type EXPERIMENTAL

LY3303560 - SC

Intervention Type DRUG

Administered SC

Interventions

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LY3303560 - IV

Administered IV

Intervention Type DRUG

Saline Solution - IV

Administered IV

Intervention Type DRUG

LY3303560 - SC

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* AD participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to AD or mild-to moderate AD and have a positive florbetapir positron emission tomography (PET) scan

Exclusion Criteria

* Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
* Have an increased risk of seizures
* For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (MRI)

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes