Health TrialsbyHealthPanel

A Study of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease (AD)

ConditionsHealthy VolunteersAlzheimer DiseaseAmyloidPlaque, AmyloidPlasma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4560736

    Drug

    Administered intravenously (IV)

  • LY4560736

    Drug

    Administered subcutaneously (SC)

  • Placebo

    Drug

    Administered IV

  • Placebo

    Drug

    Administered SC

  • Florbetapir F18

    Other intervention

    Administered IV

  • Florbetaben F 18

    Other intervention

    Administered IV

Treatment groups

111 Participants
are divided into 4 treatment groups
Group A: LY4560736 Part A: Single-Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Placebo Part APlacebo comparator 1 intervention
Group C: LY4560736 Part B: Multiple Ascending Dose (MAD)Experimental treatment 3 interventions
Group D: Placebo Part BPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame
Baseline up to 13 Weeks

Secondary outcomes

1

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) Following a Single Dose of LY4560736 in Healthy Participants

Time frame
Baseline, Week 5
2

PK: Plasma LY4560736 Maximum Concentration at Steady State (Cmax,ss) in Participants with AD

Time frame
Baseline through Week 13
3

Concentration of LY4560736 in Cerebrospinal Fluid (CSF) in Healthy Participants

Time frame
Baseline through Study Completion (13 Weeks)
4

Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD

Time frame
Baseline through Study Completion (13 Weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: