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| ID | Type | Description | Link |
|---|---|---|---|
| J4S-MC-KSAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous (into a vein) or a subcutaneous (under the skin) injection in healthy participants. Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it.
The study is conducted in two parts (part A and B), each part has a separate treatment cohort.
The study will last up to approximately 116 days for part A, and 145 days for part B, including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY3985297 (Cohorts 1-8) | Experimental | Single ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants. |
|
| Part B: LY3985297 (Cohorts 1-4) | Experimental | Multiple ascending dose of LY3985297 administered either IV or SC. |
|
| Placebo Comparator: Part A and B: Placebo | Placebo Comparator | Placebo administered either IV or SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3985297 | Drug | Administered either IV or SC. |
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| 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, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module | Baseline up to Week 13 (Part A), Week 17 (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3985297 following intravenous (IV) administration | Predose on day 1 up to Week 13 (Part A), Week 17 (Part B) | |
| PK: Cmax of LY3985297 following subcutaneous (SC) administration | Predose on day 1 up to Week 13 (Part A), Week 17 (Part B) |
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Inclusion Criteria:
For Part A Cohorts 5, 6, and 7:
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 |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States | ||
| ICON |
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| Placebo | Drug | Administered either IV or SC. |
|
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985297 following IV administration | Predose on day 1 up to Week 13 (Part A), Week 17 (Part B) |
| PK: AUC of LY3985297 following SC administration | Predose on day 1 up to Week 13 (Part A), Week 17 (Part B) |
| Bioavailability (%F) of LY3985297 following SC administration | Predose on day 1 up to Week 13 (Part A), Week 17 (Part B) |
| Salt Lake City |
| Utah |
| 84124 |
| United States |