A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)

Phase 1

Completed

Brief Summary: The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.

The study has two parts:

* Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;

* Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.

Detailed Description: In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results

Part A:

Part B:

History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
Have current serious or unstable illnesses

Arm && Interventions

Group	Intervention	Description
LY3372993 (Part A)	LY3372993	LY3372993 administered intravenously (IV) to healthy participants.
Placebo (Part A)	Placebo	Placebo administered IV to healthy participants.
LY3372993 (Part B)	LY3372993	LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.
Placebo (Part B)	Placebo	Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Day 562	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose	Predose up to Day 85	PK: Cmax of LY3372993 After a Single Dose
PK: Cmax of LY3372993 at Steady State After Multiple Doses	Week 14 through Week 18	PK: Cmax of LY3372993 at Steady State After Multiple Doses
Pharmacodynamics (PD): Change from Baseline in Amyloid Load	Baseline, Week 28	Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose	Predose up to Day 85	PK: AUC of LY3372993 After a Single Dose
PK: AUC of LY3372993 at Steady State after Multiple Doses	Week 14 through Week 18	PK: AUC of LY3372993 at Steady State after Multiple Doses

Locations (10): Avail Clinical Research LLC
🇺🇸
DeLand, Florida, United States
Progressive Medical Research
🇺🇸
Port Orange, Florida, United States
Collaborative Neuroscience Network - CNS
🇺🇸
Long Beach, California, United States
Covance Clinical Research Inc
🇺🇸
Daytona Beach, Florida, United States
MD Clinical
🇺🇸
Hallandale Beach, Florida, United States
BioClinica Inc
🇺🇸
The Villages, Florida, United States
IMIC, Inc.
🇺🇸
Palmetto Bay, Florida, United States
Atlanta Center of Medical Research
🇺🇸
Atlanta, Georgia, United States
Carolina Phase 1 Research (Wake M3)
🇺🇸
Raleigh, North Carolina, United States
PRA Health Sciences
🇺🇸
Salt Lake City, Utah, United States