RecruitingPhase 1NCT07258849

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

A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.


Sponsor

Eli Lilly and Company

Enrollment

134 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called LY4213663 — first in healthy volunteers to check safety, then in people with rheumatoid arthritis (RA) to see if it helps with joint inflammation. **You may be eligible if...** - You are a healthy adult with a BMI between 18 and 32 (healthy volunteer arm) - OR you have been diagnosed with rheumatoid arthritis for at least 3 months, weigh at least 50 kg, and have a BMI between 18 and 40 (RA arm) **You may NOT be eligible if...** - You have severe RA (Class 4 by medical guidelines) - You have had a recent active infection - You have an abnormal heart tracing (ECG) at screening - You have significant heart, lung, liver, kidney, or nerve problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4213663

Administered SC

DRUGLY4213663

Administered IV

DRUGPlacebo

Administered SC

DRUGPlacebo

Administered IV


Locations(9)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States

GNP Research at Mark Jaffe, MD

Cooper City, Florida, United States

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

Advanced Pharma CR, LLC

Miami, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Oasis Clinical Research

Las Vegas, Nevada, United States

View Full Details on ClinicalTrials.gov

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NCT07258849


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