A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3844583 in Healthy Participants, and Multiple-Dose Study of LY3844583 in Healthy Participants and Patients With Atopic Dermatitis
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. 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.
• Healthy participants (Parts A and B):
‣ Are male or female not of childbearing potential
⁃ inclusion of healthy Japanese participants, the participant must be first-generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan.
⁃ inclusion of healthy Chinse participants, the participant must be at a minimum, third-generation Chinese, defined as all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China.
⁃ Must have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive. For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m², inclusive, and a body weight of 50 kg to 85 kg, inclusive.
• Atopic dermatitis participants (Part C):
‣ Must have a body mass index of 18.0 to 45.0 kg/m², inclusive
⁃ Are male or female participants including those of child bearing potential
⁃ Must have a diagnosis of AD for at least 12 months with either poor response to topical treatments or inability to use topical treatments
⁃ Must agree to use moisturizer daily throughout the treatment period