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.
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
Pinnacle Research Group, LLC
NOT_YET_RECRUITING
Anniston
Arizona
Arizona Research Center
NOT_YET_RECRUITING
Phoenix
Florida
Clinical Research of West Florida, Inc. (Clearwater)
NOT_YET_RECRUITING
Clearwater
GNP Research at Mark Jaffe, MD
NOT_YET_RECRUITING
Cooper City
Fortrea Clinical Research Unit
RECRUITING
Daytona Beach
AGA Clinical Trials
NOT_YET_RECRUITING
Hialeah
Advanced Pharma CR, LLC
NOT_YET_RECRUITING
Miami
Floridian Clinical Research
NOT_YET_RECRUITING
Miami Lakes
Nevada
Oasis Clinical Research
NOT_YET_RECRUITING
Las Vegas
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2025-12-02
Estimated Completion Date:2028-03
Participants
Target number of participants:134
Treatments
Experimental: LY4213663 (Part A)
Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants
Placebo_comparator: Placebo (Part A)
SAD placebo administered SC and IV
Experimental: LY4213663 (Part B)
Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants
Placebo_comparator: Placebo (Part B)
MAD placebo administered SC and IV
Experimental: LY4213663 (Parts C and D)
Multiple doses of LY4213663 administered SC and IV in participants with RA