Healthy Volunteers, Alzheimer Disease, Amyloid, Plaque, Amyloid, Plasma
Conditions
Brief summary
The purpose of this study is to see how safe LY4560736 is and to see how much and how quickly LY4560736 gets into the bloodstream. For healthy participants, the study also looks at how much LY4560736 gets into the brain. This part of the study lasts up to 13 weeks which includes staying in the Clinical Research Unit (CRU) for at least 4 days. This group will include Japanese participants, and the Sponsor may choose to enroll Chinese participants. 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 13 weeks which includes staying in the CRU twice, each lasts about 1 to 2 days. Japanese participants, and potentially Chinese participants, may also be enrolled in this group.
Interventions
DRUGLY4560736
Administered intravenously (IV)
DRUGPlacebo
Administered IV
OTHERFlorbetapir F18
Administered IV
OTHERFlorbetaben F 18
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must meet eligibility criteria in the A1D-MC-ATMP screening protocol before entry into the treatment study. * To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. * To qualify as Chinese for this study, all four of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
Exclusion criteria
* Have a condition that predisposes the participant to an infection. * Have a current or recent acute, active infection. * Have active tuberculosis (TB), have or have had latent TB. * Are receiving therapeutic antibodies or expected to initiate treatment with therapeutic antibodies during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 13 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) Following a Single Dose of LY4560736 in Healthy Participants | Baseline, Week 5 |
| PK: Plasma LY4560736 Maximum Concentration at Steady State (Cmax,ss) in Participants with AD | Baseline through Week 13 |
| Concentration of LY4560736 in Cerebrospinal Fluid (CSF) in Healthy Participants | Baseline through Study Completion (13 Weeks) |
| Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD | Baseline through Study Completion (13 Weeks) |
Countries
China, Japan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed