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

• ClinicalTrials.gov Identifier: NCT02754830
• Recruitment Status: Completed
• First Posted: April 28, 2016
• Last Update Posted: July 23, 2018
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: April 26, 2016
• First Posted Date: April 28, 2016
• Last Update Posted Date: July 23, 2018
• Actual Study Start Date: April 25, 2016
• Actual Primary Completion Date: July 10, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 26, 2016): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2016)

• 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 ]
• Pharmacokinetics (Serum): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 85 days post administration of study drug ]
• Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
• Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
• Mean Change from Baseline in QT/QT Corrected (QTc) Interval [ Time Frame: Baseline, through 7 days post administration of study drug ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Alzheimer's Disease

Intervention

• Drug: LY3303560 - IV
  Administered IV
• Drug: Saline Solution - IV
  Administered IV
• Drug: LY3303560 - SC
  Administered SC

Study Arms

• Experimental: LY3303560
  Single IV infusion or SC injection of LY3303560 on Day 1
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2017): 110
• Original Estimated Enrollment (submitted: April 26, 2016): 90
• Actual Study Completion Date: July 10, 2018
• Actual Primary Completion Date: July 10, 2018 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02754830
• Other Study ID Numbers: 16120; I8G-MC-LMDA ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: July 2018