Skip to main content
OpenTrials
Completed

NCT Number: NCT02754830

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Unit at Glendale, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY3303560 - IV

Drug

Administered IV

Saline Solution - IV

Drug

Administered IV

LY3303560 - SC

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline up to 146 days

    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.

Secondary outcomes

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

    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

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

  2. PK: Maximum Drug Concentration (Cmax) of LY3303560

    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

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

  3. 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

  4. 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

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

    Time frame: Baseline, 7 days postdose

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Single-Dose, Dose-Escalation Study With LY3303560 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.