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| ID | Type | Description | Link |
|---|---|---|---|
| J4F-MC-CYAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3848575 IV | Experimental | Single ascending doses of LY3848575 administered intravenously (IV). |
|
| Placebo IV | Placebo Comparator | Placebo administered IV. |
|
| LY3848575 SC | Experimental | Multiple doses of LY3848575 administered subcutaneously (SC). |
|
| Placebo SC | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3848575 | Drug | Administered IV. |
| |
| LY3848575 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More 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 TEAEs, SAEs and Other Non-serious Adverse Events (AEs), Regardless of causality, will be reported in the Reported Adverse Events module | Baseline through 142 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV. | PK: AUC of LY3848575 When Administered IV. | End of infusion through day 85 |
| PK: AUC of LY3848575 When Administered SC. |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
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| Drug |
Administered SC. |
|
| Placebo | Drug | Administered IV. |
|
| Placebo | Drug | Administered SC. |
|
PK: AUC of LY3848575 When Administered SC.
| Predose through day 85 |