|

A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis

RECRUITINGPhase 1Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2025-12-02
Est. completion2028-03
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations9 sites

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive

Part C and D Only:

* Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg/m² (inclusive) at screening
* Have a diagnosis of adult-onset RA for at least 3 months prior to screening

Exclusion Criteria:

Healthy Participants for SAD Part A and MAD Part B Only:

* Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs

Participants with RA for Parts C and D Only:

* Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
* Have a 12-lead electrocardiogram (ECG) abnormality at screening
* Have a current or recent acute active infection

Conditions3

ArthritisHealthyRheumatoid Arthritis (RA

Locations9 sites

Pinnacle Research Group, LLC
Anniston, Alabama, 36207
256-236-0055, ext 101
Arizona Research Center
Phoenix, Arizona, 85053
602-773-3020
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
727-466-0078
GNP Research at Mark Jaffe, MD
Cooper City, Florida, 33024
754-248-3589
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.