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| ID | Type | Description | Link |
|---|---|---|---|
| J4K-MC-LALA | Other Identifier | Eli Lilly and Company | |
| 2023-504838-21-00 | EU Trial (CTIS) Number |
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The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.
Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3876602 | Experimental | Single ascending doses of LY3876602 administered intravenously (IV). |
|
| Placebo | Placebo Comparator | Placebo administered IV. |
|
| LY3876602 Part B (MAD) | Experimental | Multiple ascending doses of LY3876602 will be administered intravenously (IV). |
|
| Placebo: Part B (MAD) | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3876602 | Drug | Administered IV. |
| |
| 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 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602 | PK: AUC of LY3876602 | Predose up to 28 weeks |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3876602 |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | Groningen | 9728 NZ | Netherlands |
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| Placebo |
| Drug |
Administered IV. |
|
PK: Cmax of LY3876602
| Predose up to 28 weeks |
| PK: Half-life (t1/2) of LY3876602 | PK: t1/2 of LY3876602 | Predose up to 28 weeks |