A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis

J3V-MC-KKAA -

The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis. The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis.

Trial Summary

Age Range
18 - 65 years
Conditions the trial is for
Atopic Dermatitis (Eczema)
What the trial is testing?
LY3844583
Could I receive a Placebo?
Yes
Enrollment Goal
102
Trial Dates
Aug 11, 2022 - Jan 20, 2024
How long will I be in the trial?
The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 88, 116, and 186 days with 10, 13, and 14 visits for each participant in parts A, B, and C, respectively.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

Healthy participants (parts A and B):

  • Participant must be male or female and not of childbearing potential

  • Participants must be overtly healthy, as determined by medical evaluation. Japanese and Chinese participants are also included

  • Participants must have a body mass index (BMI) ranging from 18.0 to 32.0 kilograms per meter squared (kg/m2). Healthy Japanese participants should have a BMI of 18.0 to 28.0 kg/m2 and a body weight of 50 kg to 85 kg

Atopic dermatitis (AD) participants (part C):

  • Participant must be male or female participants including those of child bearing potential

  • Participants must have AD that has been present for at least one year with inadequate response to topical medications (medications applied to the skin)

  • Participants must agree to use a lotion or cream that softens the skin daily

Participants Must Not:

All participants:

  • Participants must not have or have had any health problems, laboratory tests results, or electrocardiogram (ECG) readings that, in the doctor's opinion, could make participation unsafe or interfere with understanding the study's results

  • Participants must not have a history of cancer within 5 years

  • Participants must not have tuberculosis (TB) or inflammation of the liver (hepatitis) or human immunodeficiency virus (HIV)

  • Participants must not have received a vaccine within 28 days of beginning the study

Atopic dermatitis participants:

  • Participant must not have used any topical AD treatment within the previous two weeks of treatment assignment

  • Participants must not have received certain oral medications or light therapy for AD within four weeks of treatment assignment

  • Participants must not have received injectable steroids within the previous 6 weeks of treatment assignment

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