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NCT07258849 | RECRUITING | Healthy

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

Eli Lilly and Company

Brief 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.

Condition or disease

Healthy

Rheumatoid Arthritis (RA)

Intervention/treatment

LY4213663

LY4213663

Placebo

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 134 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : 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.
Actual Study Start Date : 2025-12-02
Estimated Primary Completion Date : 2028-03
Estimated Study Completion Date : 2028-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis

Location Details

NCT07258849

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, alabama

Pinnacle Research Group, LLC

Anniston, alabama, United States, 36207

NOT YET RECRUITING

United States, Arizona

Arizona Research Center

Phoenix, arizona, United States, 85053

NOT YET RECRUITING

United States, Florida

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, florida, United States, 33765

NOT YET RECRUITING

United States, Florida

GNP Research at Mark Jaffe, MD

Cooper City, florida, United States, 33024

RECRUITING

United States, Florida

Fortrea Clinical Research Unit

Daytona Beach, florida, United States, 32117

NOT YET RECRUITING

United States, Florida

AGA Clinical Trials

Hialeah, florida, United States, 33012

NOT YET RECRUITING

United States, Florida

Advanced Pharma CR, LLC

Miami, florida, United States, 33417

NOT YET RECRUITING

United States, Florida

Floridian Clinical Research

Miami Lakes, florida, United States, 33016

NOT YET RECRUITING

United States, Nevada

Oasis Clinical Research

vegas, Nevada, United States, 89121