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.
Eli Lilly and Company
134 participants
Dec 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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
Interventions
Administered SC
Administered IV
Administered SC
Administered IV
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT07258849