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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMCG | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab (Test Arm 1) | Experimental | Mirikizumab administered subcutaneously (SC) |
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| Mirikizumab (Test Arm 2) | Experimental | Mirikizumab administered SC |
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| Mirikizumab (Reference Arm) | Experimental | Mirikizumab administered SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 | Day 1 through Day 71 | |
| PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828 | Day 1 through Day 71 |
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Inclusion Criteria:
Are overtly healthy males or females as determined by medical evaluation including:
Have clinical laboratory test results at screening and Day -1 within normal reference range.
Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Recruiting | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Axis Clinicals LLC | Recruiting | Dilworth | Minnesota | 56529 | United States |
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| Fortrea Clinical Research Unit | Recruiting | Dallas | Texas | 75247 | United States |
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| Worldwide Clinical Trials, Inc. | Recruiting | San Antonio | Texas | 78217 | United States |
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| Fortrea Clinical Research Unit | Recruiting | Madison | Wisconsin | 53704 | United States |
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