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| ID | Type | Description | Link |
|---|---|---|---|
| J3K-MC-KIAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 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 113 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3541860 (Part A) | Experimental | Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC). |
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| LY3541860 (Part B) | Experimental | Multiple doses of LY3541860 administered either IV or SC. |
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| Placebo (Part A) | Placebo Comparator | Single doses of Placebo administered either IV or SC. |
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| Placebo (Part B) | Placebo Comparator | Multiple doses of Placebo administered either IV or SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3541860 | Drug | Administered either IV or SC. |
| |
| 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 Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860 | PK: Cmax of LY3541860 | Predose on Day 1 through Day 113 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860 |
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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 |
|---|---|---|---|---|---|---|
| P-One Clinic | HachiĆji | Tokyo | 192-0071 | Japan |
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| Placebo |
| Drug |
Administered either IV or SC. |
|
PK: AUC of LY3541860
| Predose on Day 1 through Day 113 |