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| ID | Type | Description | Link |
|---|---|---|---|
| J7A-MC-NGAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4302814 IV | Experimental | LY4302814 administered intravenously (IV) |
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| Placebo IV | Placebo Comparator | Placebo administered IV |
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| LY4302814 SC | Experimental | LY4302814 administered subcutaneously (SC) |
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| Placebo SC | Placebo Comparator | Placebo administered SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4302814 | Drug | Administered SC |
| |
| LY4302814 |
| 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 | Day 1 through Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814 | Day 1 through Day 197 | |
| PK: Maximum Concentration (Cmax) of LY4302814 | Day 1 through Day 197 |
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Inclusion Criteria:
Are overtly healthy as determined by medical evaluation.
Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator.
Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Adult participants in Singapore:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Recruiting | Daytona Beach | Florida | 32117 | United States |
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| Drug |
Administered IV |
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| Placebo | Drug | Administered SC |
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| Placebo | Drug | Administered IV |
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| Lilly Centre for Clinical Pharmacology | Recruiting | Singapore | 138623 | Singapore |
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