Actively Recruiting
A Phase 1, Randomized, Placebo-Controlled Study of LY4213663 Evaluating Safety, Tolerability, and Pharmacokinetics in Healthy Adults and Adults With Rheumatoid Arthritis
Led by Eli Lilly and Company · Updated on 2026-05-22
141
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying LY4213663 to understand how well it is tolerated and what side effects it may cause in both healthy adults and those with rheumatoid arthritis (RA). The trial is a Phase 1, randomized, placebo-controlled study led by Eli Lilly and Company, aiming to evaluate the safety, tolerability, and how the body processes LY4213663. This study includes adults aged 18 to 75 years and will last about 33 weeks, not counting the screening period. Participants will receive LY4213663 either under the skin (subcutaneously) or into a vein in the arm (intravenously). The study has several parts: single-ascending doses and multiple-ascending doses given to healthy participants, with matching placebo groups, as well as multiple doses given to participants with rheumatoid arthritis. Treatments are randomized and include both the study drug and placebo administered in different ways. During the study, blood tests will be taken to monitor how the drug is processed and its effects on the body. Researchers will track any serious side effects related to the drug from the start through 33 weeks. Participants will have regular assessments, including safety and pharmacokinetic evaluations, to measure the drug levels in their system. The study also carefully monitors participants with RA for any changes or infections throughout the trial.
CONDITIONS
Brief Title
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Body mass index (BMI) between 18.0 and 32.0 kg/m² for healthy participants
- For participants with rheumatoid arthritis (Parts C and D): weight at least 50 kilograms and BMI between 18.0 and 40.0 kg/m²
- Diagnosis of adult-onset rheumatoid arthritis for at least 3 months prior to screening (Parts C and D)
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, eye, kidney, gastrointestinal, endocrine, blood, nervous system, or psychiatric disorders affecting drug processing (for healthy participants in Parts A and B)
- Class 4 rheumatoid arthritis according to American College of Rheumatology criteria (for participants with RA in Parts C and D)
- Abnormal 12-lead electrocardiogram at screening (for participants with RA in Parts C and D)
- Current or recent acute active infection (for participants with RA in Parts C and D)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 33 weeks
Participants receive single or multiple ascending doses of LY4213663 or placebo administered subcutaneously or intravenously depending on the study part and participant group.
Multiple dosing visits over the treatment period
Trial Site Locations
Total: 10 locations
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Actively Recruiting
2
Arizona Research Center
Phoenix, Arizona, United States, 85053
Actively Recruiting
3
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States, 33765
Actively Recruiting
4
GNP Research at Mark Jaffe, MD
Cooper City, Florida, United States, 33024
Actively Recruiting
5
Fortrea Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Actively Recruiting
6
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Actively Recruiting
7
Advanced Pharma CR, LLC
Miami, Florida, United States, 33417
Actively Recruiting
8
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
9
Oasis Clinical Research
Las Vegas, Nevada, United States, 89121
Actively Recruiting
10
Universitätsklinikum Charité
Berlin, Germany, 10117
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
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