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NCT07258849PHASE1RecruitingAccepts Healthy Volunteers

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

Eli Lilly and Company

Start Date

12/2/2025

Completion Date

3/1/2028

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 Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

LY4213663

DRUG

LY4213663

DRUG

Placebo

DRUG

Placebo

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Conditions

Rheumatoid Arthritis (RA)

Locations

Pinnacle Research Group, LLC

Anniston, Alabama 36207

United States

Arizona Research Center

Phoenix, Arizona 85053

United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida 33765

United States

GNP Research at Mark Jaffe, MD

Cooper City, Florida 33024

United States

Fortrea Clinical Research Unit

Daytona Beach, Florida 32117

United States

AGA Clinical Trials

Hialeah, Florida 33012

United States

Advanced Pharma CR, LLC

Miami, Florida 33417

United States

Floridian Clinical Research

Miami Lakes, Florida 33016

United States

Oasis Clinical Research

Las Vegas, Nevada 89121

United States

Universitätsklinikum Charité

Berlin, 10117

Germany