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| ID | Type | Description | Link |
|---|---|---|---|
| I9N-MC-FCAC | Other Identifier | Eli Lilly and Company |
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The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY3375880 Formulation A | Experimental | LY3375880 Formulation A administered subcutaneously (SC). |
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| Part A: LY3375880 Formulation B | Experimental | LY3375880 Formulation B administered subcutaneously SC. |
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| Part A: LY3375880 Formulation C | Experimental | LY3375880 Formulation C administered SC. |
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| Part A: Positive Control | Placebo Comparator | Positive Control (buffer matrix, only) administered SC. |
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| Part B: LY3375880 Test 1 | Experimental | LY3375880 Test 1 Formulation administered SC. |
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| Part B: LY3375880 Test 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3375880 | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain). | Part A: Within 1-minute post injection |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880 | PK: Cmax of LY3375880 | Part B: Predose through Day 85 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880 | PK: AUC of LY3375880 | Part B: Predose through Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| Covance |
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Part A is a crossover design. Part B is a parallel design.
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LY3375880 Test 2 Formulation administered SC. |
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| Part B: LY3375880 Test 3 | Experimental | LY3375880 Test 3 Formulation administered SC. |
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| Buffer Matrix (No LY3375880) | Drug | Administered SC |
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| Autoinjector (AI) | Device | AI used to administer LY3375880 or Buffer Matrix |
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| Manual Syringe | Device | Manual syringe used to inject LY3375880 |
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| Dallas |
| Texas |
| 75247 |
| United States |