A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis
- Conditions
- Atopic DermatitisHealthy
- Interventions
- Registration Number
- NCT06119529
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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 44 days for parts A, B, and C, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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
- Women who are pregnant and/or lactating
- Participants who 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
- Have a known history of diabetes
- Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening
- Have known history of osteoporosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: LY3872386 LY3872386 Single doses of LY3872386 administered either intravenously (IV) or subcutaneously (SC) in healthy participants. Placebo Placebo Placebo administered either IV or SC. Part B: LY3872386 LY3872386 Multiple doses of LY3872386 administered either IV or SC in participants with atopic dermatitis. Part C: Prednisone Prednisone Prednisone administered orally in healthy participants.
- Primary Outcome Measures
Name Time Method 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 Baseline through Day 85 A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
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 Baseline through Day 183 A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
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 Baseline through Day 44 A summary of TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method Part C: AUC of Prednisone and Prednisolone Predose up to 12 hours post dose on day 14 and day 30 Part C: Cmax of Prednisone and Prednisolone Predose up to 12 hours post dose on day 14 and day 30 Part A and B: Maximum Observed Concentration (Cmax) of LY3872386 Predose up to 85 days (Part A) and 183 days (Part B) Pharmacokinetic (PK) parameter is determined after administration of LY3872386
Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386 Predose up to 85 days (Part A) and 183 days (Part B) PK parameter is determined after administration of LY3872386
Trial Locations
- Locations (2)
CenExel ACT
🇺🇸Anaheim, California, United States
Fortrea Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States