A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 58 days for parts A, B, and C, respectively.

Official Title
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A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.

Conditions
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Healthy, Atopic Dermatitis

Intervention / Treatment
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* Drug: LY3872386
* Drug: Prednisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part A and C: Overtly healthy as determined by medical evaluation To qualify as Japanese for the purpose of this study, 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 To qualify as Chinese for the purpose of this study, the participant must be, at a minimum, third-generation Chinese, defined as all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part A and C Part B: Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive Male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part B Exclusion Criteria: Women who are pregnant and/or lactating Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette- Guérin within 35 days of screening Have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: LY3872386<br>Single doses of LY3872386 administered either intravenously (IV) or subcutaneously (SC) in healthy participants. | Drug: LY3872386<br>* Administered either IV or SC.<br>|
| Experimental: Part B: LY3872386<br>Multiple doses of LY3872386 administered either IV or SC in participants with atopic dermatitis. | Drug: LY3872386<br>* Administered either IV or SC.<br>|
| Experimental: Part C: Prednisone<br>Prednisone administered orally in healthy participants. | Drug: Prednisone<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<br>Placebo administered either IV or SC. | Drug: Placebo<br>* Administered either IV or SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and other non-serious adverse events (AEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 85 | 
| Part B: Number of Participants with One or More TEAEs, SAEs and other non-serious AEs Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 183 | 
| Part C: Number of Participants with One or More TEAEs, SAEs and other non-serious AEs Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3872386 | PK: Cmax of LY3872386 | Predose up to 85 days (Part A) and 183 days (Part B) | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3872386 | PK: AUC of LY3872386 | Predose up to 85 days (Part A) and 183 days (Part B) | 
| PK: Cmax of Prednisone | PK: Cmax of Prednisone | Predose up to 12 hours post dose on day 14 and day 30 | 
| PK: AUC of Prednisone | PK: AUC of Prednisone | Predose up to 12 hours post dose on day 14 and day 30 | 
| PK: Cmax of Prednisolone | PK: Cmax of Prednisolone | Predose up to 12 hours post dose on day 14 and day 30 | 
| PK: AUC of Prednisolone | PK: AUC of Prednisolone | Predose up to 12 hours post dose on day 14 and day 30 |