A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease

Eli Lilly and Company

Summary

The purpose of this study is to see how safe LY4405094 is and to see how much and how quickly LY4405094 gets into the bloodstream. For healthy participants, the study also looks at how much LY4405094 gets into the fluid around the brain and lasts up to 13 weeks and will include a 4-day stay in the Clinical Research Unit (CRU). For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 25 weeks and will include a 3-day stay in the CRU.

Eligibility

Age range: 18–85 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study. Exclusion Criteria: * Have known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY4405094. * Have known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.

Interventions

Drug
LY4405094
Administered intravenously (IV)
Drug
LY4405094
Administered Subcutaneously (SC)
Drug
Placebo
Administered IV
Drug
Placebo
Administered SC
Other
Florbetapir F18
Administered IV
Other
Florbetaben F 18
Administered IV

Locations (10)

Irvine Clinical Research
Irvine, California
Fortrea Clinical Research Unit
Daytona Beach, Florida
386-366-6400
K2 Medical Research - The Villages
Lady Lake, Florida
K2 Medical Research
Maitland, Florida
Charter Research
Orlando, Florida
Progressive Medical Research
Port Orange, Florida