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

NCT02754830 | Completed Phase 1 Results

• 2 other identifiers: 16120I8G-MC-LMDA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to 146 days

Secondary Outcomes (5)

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

  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

  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)

  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)

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

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

  Baseline, 7 days postdose

Study Arms (3)

LY3303560

EXPERIMENTAL

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.

Drug: LY3303560 - IV

Saline Solution

PLACEBO COMPARATOR

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

Drug: Saline Solution - IV

LY3303560 Subcutaneous (SC)

EXPERIMENTAL

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

Drug: LY3303560 - SC

Interventions

LY3303560 - IV DRUG

Administered IV

LY3303560

Saline Solution - IV DRUG

Administered IV

Saline Solution

LY3303560 - SC DRUG

Administered SC

LY3303560 Subcutaneous (SC)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206, United States

Location

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Related Links

• Click here for more information about this study: A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Planned doses of 2800 mg and 5600 mg in AD participants were not implemented.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 28, 2016
• Study Start: April 25, 2016
• Primary Completion: July 10, 2018
• Study Completion: July 10, 2018
• Last Updated: October 13, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-10

Locations

US (2)