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| ID | Type | Description | Link |
|---|---|---|---|
| J3E-MC-EZDA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3540378 in healthy participants following single and multiple doses (Parts A and B) and multiple doses in Japanese (Part C) and Chinese (Part D) healthy participants. Blood tests will be performed to check how much LY3540378 gets into the bloodstream and how long it takes the body to eliminate it. This is a 4-part study and may last up to 70, 113, 113 and 113 days for each participant in Parts A, B, C, and D respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3540378 (Part A) | Experimental | Single ascending doses of LY3540378 administered either intravenously (IV) or subcutaneously (SC). |
|
| LY3540378 (Part B) | Experimental | Multiple ascending doses of LY3540378 administered SC. |
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| LY3540378 (Part C) | Experimental | Multiple ascending doses of LY3540378 administered SC in Japanese Participants. |
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| LY3540378 (Part D) | Experimental | Multiple ascending doses of LY3540378 administered SC in Chinese Participants. |
|
| Placebo (Part A, B, C & D) | Placebo Comparator | Placebo administered either IV or SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3540378 | Drug | Administered IV or SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3540378 | PK: Cmax of LY3540378 | Predose on Day 1 through Day 113 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3540378 |
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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 | ||
| Lilly Centre for Clinical Pharmacology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38782726 | Derived | Tham LS, Heerspink HJL, Wang X, Verdino P, Saifan CG, Benson EA, Goldsmith P, Wang Z, Testani JM, Haupt A, Sam F, Cherney DZI. Volenrelaxin (LY3540378) increases renal plasma flow: a randomized Phase 1 trial. Nephrol Dial Transplant. 2024 Dec 20;40(1):109-122. doi: 10.1093/ndt/gfae112. |
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| Drug |
Administered IV or SC. |
|
| LY3540378 | Drug | Administered SC. |
|
PK: AUC of LY3540378
| Predose on Day 1 through Day 113 |
| Singapore |
| 138623 |
| Singapore |