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| ID | Type | Description | Link |
|---|---|---|---|
| J7G-MC-OEAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b) | Experimental | LY4178256 or Placebo administered Intravenously (IV) |
|
| LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3) | Experimental | LY4178256 or Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4178256 | Drug | Administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: 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 Adverse Events module | Screening to Day 169 |
| Part B: 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 Adverse Events module | Screening to Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256 | To evaluate PK after a single dose of LY4178256 | Predose up to Day 8 |
| Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256 |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network - CNS | Los Alamitos | California | 90720 | United States |
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| Placebo | Drug | Administered IV |
|
To evaluate PK after multiple doses [LC14.1]of LY4178256 |
| Predose up to Day 64 |
| ICON | Salt Lake City | Utah | 84124 | United States |
|