A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis
Study Details
Study Description
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 58 days for parts A, B, and C, respectively.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: LY3872386 Single doses of LY3872386 administered either intravenously (IV) or subcutaneously (SC) in healthy participants. |
Drug: LY3872386
Administered either IV or SC.
|
| Experimental: Part B: LY3872386 Multiple doses of LY3872386 administered either IV or SC in participants with atopic dermatitis. |
Drug: LY3872386
Administered either IV or SC.
|
| Experimental: Part C: Prednisone Prednisone administered orally in healthy participants. |
Drug: Prednisone
Administered orally.
|
| Placebo Comparator: Placebo Placebo administered either IV or SC. |
Drug: Placebo
Administered either IV or SC.
|
Outcome Measures
Primary Outcome Measures
- 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 48]
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
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3872386 [Predose up to 85 days (Part A) and 183 days (Part B)]
PK: Cmax of LY3872386
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3872386 [Predose up to 85 days (Part A) and 183 days (Part B)]
PK: AUC of LY3872386
- PK: Cmax of Prednisone [Predose up to 12 hours post dose on day 14 and day 30]
PK: Cmax of Prednisone
- PK: AUC of Prednisone [Predose up to 12 hours post dose on day 14 and day 30]
PK: AUC of Prednisone
- PK: Cmax of Prednisolone [Predose up to 12 hours post dose on day 14 and day 30]
PK: Cmax of Prednisolone
- PK: AUC of Prednisolone [Predose up to 12 hours post dose on day 14 and day 30]
PK: AUC of Prednisolone
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fortrea Clinical Research Unit | Daytona Beach | Florida | United States | 32117 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18607
- J4L-MC-KMAA