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| ID | Type | Description | Link |
|---|---|---|---|
| J5S-MC-CEAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY4088044 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 LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4088044 (Part A) | Experimental | Single-ascending dose (SAD) of LY4088044 administered intravenously (IV) |
|
| Placebo (Part A) | Placebo Comparator | Administered IV |
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| LY4088044 (Part B) | Experimental | SAD of LY4088044 administered subcutaneously (SC) |
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| Placebo (Part B) | Placebo Comparator | Administered SC |
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| LY4088044 (Part C) | Experimental | Multiple-ascending doses (MAD) of LY4088044 administered IV |
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| Placebo (Part C) | Placebo Comparator | Administered IV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4088044 | 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 regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Day 190 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044 | PK: Cmax of LY4088044 | Baseline up to Approximately Day 190 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044 |
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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 | Recruiting | Los Alamitos | California | 90720 | United States |
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Sponsor is blinded
| LY4088044 |
| Drug |
Administered SC |
|
| Placebo | Drug | Administered IV |
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| Placebo | Drug | Administered SC |
|
PK: AUC of LY4088044
| Baseline up to Approximately Day 190 |
| Pharmacodynamics (PD): Protein Levels in Skin Samples | PD: Percent Decrease in Protein Levels | Baseline up to Approximately Day 190 |
| ICON | Not yet recruiting | Lenexa | Kansas | 66219 | United States |
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| ICON Early Phase Services | Recruiting | San Antonio | Texas | 78232 | United States |
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| ICON | Recruiting | Salt Lake City | Utah | 84124 | United States |
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| New Zealand Clinical Research Christchurch | Not yet recruiting | Christchurch | 8011 | New Zealand |
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| Lilly Centre for Clinical Pharmacology | Recruiting | Singapore | 138623 | Singapore |
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