Testing LY4213663 for safety in healthy people and rheumatoid arthritis patients
Tests LY4213663 in healthy adults and adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
Key facts
- Where
- Anniston, Clearwater, Cooper City, Daytona Beach, Hialeah, Las Vegas, Miami, Miami Lakes, and Phoenix, United StatesSee the 9 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07258849, who can take part
Where in United States
- Pinnacle Research Group, LLCAnniston, United StatesTaking people
- Clinical Research of West Florida, Inc. (Clearwater)Clearwater, United StatesTaking people
- GNP Research at Mark Jaffe, MDCooper City, United StatesTaking people
- Fortrea Clinical Research UnitDaytona Beach, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesTaking people
- Oasis Clinical ResearchLas Vegas, United StatesTaking people
- Advanced Pharma CR, LLCMiami, United StatesTaking people
- Floridian Clinical ResearchMiami Lakes, United StatesTaking people
- Arizona Research CenterPhoenix, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07258849EU 2025-523980-39-00
- Record updated
- 23 June 2026
- Original description
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).Read full original descriptionShow less
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.
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.
Inclusion: 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: 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; 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.