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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754830
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

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 42 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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY3303560 - IV Drug: Saline Solution - IV Drug: LY3303560 - SC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3303560
Single IV infusion or SC injection of LY3303560 on Day 1
 Drug: LY3303560 - IV
Administered IV

Drug: LY3303560 - SC
Administered SC
Placebo Comparator: Saline Solution
Single IV infusion of saline solution to match LY3303560 on Day 1
 Drug: Saline Solution - IV
Administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Predose through 85 days post administration of study drug ]

Secondary Outcome Measures :
  1. Pharmacokinetics (Serum): Area Under the Concentration Versus Time Curve from Time 0 to Infinity (AUC[0-∞]) of LY3303560 [ Time Frame: Predose through 85 days post administration of study drug ]
  2. Pharmacokinetics (Serum): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 85 days post administration of study drug ]
  3. Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
  4. Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
  5. Mean Change from Baseline in QT/QT Corrected (QTc) Interval [ Time Frame: Baseline, through 7 days post administration of study drug ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754830


Locations
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United States, California
Parexel Early Phase Unit at Glendale
Glendale, California, United States, 91206
United States, Maryland
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02754830    
Other Study ID Numbers: 16120
I8G-MC-LMDA ( Other Identifier: Eli Lilly and Company )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders