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| ID | Type | Description | Link |
|---|---|---|---|
| J3V-MC-KKAA | Other Identifier | Eli Lilly and Company |
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Study terminated due to lack of efficacy signal in atopic dermatitis participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3844583 (Part A) | Experimental | Single doses of LY3844583 administered subcutaneously (SC) and/or intravenously (IV). |
|
| LY3844583 (Part B) | Experimental | Multiple doses of LY3844583 administered SC and/or IV. |
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| LY3844583 (Part C) | Experimental | Repeat doses of LY3844583 administered SC and/or IV. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC and/or IV. |
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| Placebo (Part B) | Placebo Comparator | Placebo administered SC and/or IV. |
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| Placebo (Part C) | Placebo Comparator | Placebo administered SC and/or IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3844583 | Drug | Administered SC and/or IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of AEs, TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Day 186 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3844583 | PK: Cmax of LY3844583 | Pre-dose on Day 1 up to 186 days post-dose |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3844583 |
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Inclusion Criteria:
Healthy participants (Parts A and B):
Atopic dermatitis participants (Part C):
Exclusion Criteria:
All participants:
Atopic dermatitis participants:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206-4140 | United States | ||
| Medical Corporation Heishinkai OPHAC Hospital |
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| Label | URL |
|---|---|
| A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | Administered SC and/or IV. |
|
PK: AUC of LY3844583
| Pre-dose on Day 1 up to 186 days post-dose |
| Osaka |
| Osaka |
| 532-0003 |
| Japan |
| P-one clinic | HachiĆji | Tokyo | 192-0071 | Japan |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |