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| ID | Type | Description | Link |
|---|---|---|---|
| J5D-MC-FPAB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4005130 gets into the bloodstream and how long it takes the body to eliminate it.
Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 26 weeks with 14 visits not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4005130 Part A (SAD) SC | Experimental | A single-ascending dose of LY4005130 administered subcutaneously (SC) |
|
| Placebo Part A (SAD) SC | Placebo Comparator | Placebo administered SC |
|
| LY4005130 Part A (SAD) IV | Experimental | A single-ascending dose of LY4005130 administered intravenously (IV) |
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| Placebo Part A (SAD) IV | Placebo Comparator | Placebo administered IV |
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| LY4005130 Part A (SAD) Optional | Experimental | A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts |
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| Placebo Part A (SAD) Optional | Placebo Comparator | A single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4005130 | Drug | Administered IV |
|
| 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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to Study Completion (Up to 26 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4005130 | Cmax of LY4005130 | Baseline to Study Completion (Up to 26 Weeks) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4005130 |
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Inclusion Criteria:
Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram) ECG. If any values are outside the normal range and considered to be significant, for example, elevated white blood cell count, the respective test may be repeated once at the discretion of the investigator without consultation with the sponsor
If enrolled as Japanese or Chinese, the entry requirements are as follows:
Have a body weight 45 kilogram (kg) or greater and body mass index greater than 18 and less than 32 kilogram per square meter (kg/m²)
Exclusion Criteria:
Are an individual of childbearing potential (IOCBP)
Have known allergies to LY4005130, related compounds, or any components of the formulation
Have received a live vaccine within 28 days of screening or intend to do so during the study or within 28 days after the study
Had a surgical procedure within 12 weeks before screening;
Have a history of allergy to medications that could be used to treat infusion reactions, or to the drug excipients
Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, significant history of atopy, or a history of severe posttreatment hypersensitivity reactions. These reactions include, but are not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis
Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions
Have had breast cancer within the past 10 years
Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
Have a current or recent acute, active infection
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| 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 | Dallas | Texas | 75247 | United States |
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| LY4005130 Part B (MAD) IV | Experimental | Multiple-ascending doses of LY4005130 administered IV |
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| Placebo Part B (MAD) IV | Placebo Comparator | Placebo administered IV |
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| LY4005130 Part B (MAD) SC or IV | Experimental | Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts |
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| Placebo Part B (MAD) SC or IV | Placebo Comparator | Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts |
|
| LY4005130 Part B (MAD) Optional | Experimental | Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts |
|
| Placebo Part B (MAD) Optional | Placebo Comparator | Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts |
|
| LY4005130 | Drug | Administered SC |
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| Placebo | Drug | Administered IV |
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| Placebo | Drug | Administered SC |
|
AUC of LY4005130
| Baseline to Study Completion (Up to 26 Weeks) |