The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD). Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
128
Administered IV
Administered IV
Collaborative Neuroscience Network - CNS
Los Alamitos, California, United States
RECRUITINGK2 Medical Research - The Villages
Lady Lake, Florida, United States
RECRUITINGK2 Medical Research
Maitland, Florida, United States
RECRUITINGAtlanta Center of Medical Research
Atlanta, Georgia, United States
RECRUITINGCenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, United States
RECRUITINGCenExel-HRI
Marlton, New Jersey, United States
RECRUITINGDuke Early Phase Research Unit
Durham, North Carolina, United States
NOT_YET_RECRUITINGNumber of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline to Study Completion (Up to 61 Weeks)
PK: Maximum Concentration (Cmax) of LY4006895
PK: Cmax of LY4006895
Time frame: Baseline to Study Completion (Up to 61 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895
PK: AUC of LY4006895
Time frame: Baseline to Study Completion (Up to 61 Weeks)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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