NCT07258849RecruitingPhase 1
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.
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 141 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 2 Dec 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07258849
- EU CT number
- 2025-523980-39-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 141
- From 2 Dec 2025 to the primary completion date, Mar 2028
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 a current or recent acute active infection
Other
- Healthy Participants for SAD Part A and MAD Part B Only:
- Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
- Have a 12-lead electrocardiogram (ECG) abnormality at screening
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Recruiting |
| Clinical Research of West Florida, Inc. (Clearwater) Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| GNP Research at Mark Jaffe, MD Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| Fortrea Clinical Research Unit Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| AGA Clinical Trials Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Oasis Clinical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Advanced Pharma CR, LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Floridian Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Arizona Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.