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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523980-39-00 | EU Trial (CTIS) Number | ||
| J6T-MC-KYAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). 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 investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4213663 (Part A) | Experimental | Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants |
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| Placebo (Part A) | Placebo Comparator | SAD placebo administered SC and IV |
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| LY4213663 (Part B) | Experimental | Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants |
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| Placebo (Part B) | Placebo Comparator | MAD placebo administered SC and IV |
|
| LY4213663 (Parts C and D) | Experimental | Multiple doses of LY4213663 administered SC and IV in participants with RA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4213663 | Drug | Administered SC |
|
| 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 Week 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663 | PK: Cmax of LY4213663 | Baseline up to Week 33 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663 | PK: AUC of LY4213663 |
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Inclusion Criteria:
Part C and D Only:
Exclusion Criteria:
Healthy Participants for SAD Part A and MAD Part B Only:
Participants with RA for Parts C and D Only:
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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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Recruiting | Anniston | Alabama | 36207 | United States |
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| Label | URL |
|---|---|
| A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis | View source |
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| LY4213663 | Drug | Administered IV |
|
| Placebo | Drug | Administered SC |
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| Placebo | Drug | Administered IV |
|
| Baseline up to Week 33 |
| Arizona Research Center | Recruiting | Phoenix | Arizona | 85053 | United States |
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| Clinical Research of West Florida, Inc. (Clearwater) | Recruiting | Clearwater | Florida | 33765 | United States |
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| GNP Research at Mark Jaffe, MD | Recruiting | Cooper City | Florida | 33024 | United States |
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| Fortrea Clinical Research Unit | Recruiting | Daytona Beach | Florida | 32117 | United States |
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| AGA Clinical Trials | Recruiting | Hialeah | Florida | 33012 | United States |
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| Advanced Pharma CR, LLC | Recruiting | Miami | Florida | 33417 | United States |
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| Floridian Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Oasis Clinical Research | Recruiting | Las Vegas | Nevada | 89121 | United States |
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| Universitätsklinikum Charité | Not yet recruiting | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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