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

Eli Lilly and Company72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Parexel Early Phase Unit at Glendale

Glendale, California, United States

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration

Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame: Baseline up to 146 days

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560

Serum PK: AUC. Statistical analysis was not pre-specified.

Time frame: Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

PK: Maximum Drug Concentration (Cmax) of LY3303560

Serum PK: Cmax. Statistical analysis was not pre-specified.

Time frame: Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

Mean Change From Baseline in QT/QT Corrected (QTc) Interval

Mean change from baseline in QT/QTc intervals using Fridericia's formula \[Fridericia's corrected QT(QTcF)\] from ECG monitoring.

Time frame: Baseline, 7 days postdose