LY4213663 in healthy people and people 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.
This will test whether LY4213663 is safe and how the body handles it in healthy volunteers and people with rheumatoid arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 9 sites (Anniston, Alabama and 8 other locations) |
| Trial ID | NCT07258849 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, first-in-human/early clinical program that gives LY4213663 either under the skin (subcutaneous) or into a vein (intravenous) to healthy volunteers and to people with rheumatoid arthritis. The study includes single- and multiple-dose groups and contains placebo arms for comparison. Blood tests will measure how the drug is processed (pharmacokinetics) and any biological effects or safety signals (pharmacodynamics and adverse events). The active treatment and follow-up period lasts about 33 weeks excluding screening.
Who should consider this trial
Good fit: Adults with adult-onset rheumatoid arthritis for at least three months who meet the trial's weight and BMI requirements and who do not have Class 4 disease, ECG abnormalities, or active infections are the intended participants.
Not a fit: People with Class 4 RA, current acute infections, significant cardiac or other major organ disease, ECG abnormalities, or who fall outside the study's BMI/weight windows are unlikely to receive benefit from participating.
Why it matters
Potential benefit: If LY4213663 is well tolerated and shows appropriate blood-levels, it could advance toward later trials and potentially become a new option for people with rheumatoid arthritis.
How similar studies have performed: Although other biologic agents for RA have succeeded in later-phase trials, LY4213663 is an experimental early-phase agent and has not yet been shown effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anniston, Alabama and 8 other locations
- Pinnacle Research Group, LLC — Anniston, Alabama, United States (Recruiting)
- Arizona Research Center — Phoenix, Arizona, United States (Recruiting)
- Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States (Not_yet_recruiting)
- GNP Research at Mark Jaffe, MD — Cooper City, Florida, United States (Recruiting)
- Fortrea Clinical Research Unit — Daytona Beach, Florida, United States (Recruiting)
- AGA Clinical Trials — Hialeah, Florida, United States (Recruiting)
- Advanced Pharma CR, LLC — Miami, Florida, United States (Recruiting)
- Floridian Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Oasis Clinical Research — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.