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| ID | Type | Description | Link |
|---|---|---|---|
| I9N-MC-FCAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.
This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3375880 Single Dose | Experimental | Single dose of LY3375880 administered IV or SC |
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| Placebo Single Dose | Placebo Comparator | Single dose of placebo administered IV or SC |
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| LY3375880 Multiple Dose | Experimental | Multiple doses of LY3375880 administered IV or SC |
|
| Placebo Multiple Dose | Placebo Comparator | Multiple doses of placebo administered IV or SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3375880 IV | 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 | Pre-dose to 3 months after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880 | PK: Cmax of LY3375880 | Pre-dose to 3 months after administration of study drug |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880 |
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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 |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206 | United States |
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| LY3375880 SC |
| Drug |
administered SC |
|
| Placebo IV | Drug | administered IV |
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| Placebo SC | Drug | administered SC |
|
PK: AUC of LY3375880
| Pre-dose to 3 months after administration of study drug |