A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
Recruiting · NCT07258849 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
LY4213663Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
10 locations listed across 4 US states.
- Pinnacle Research Group, LLC - Anniston, Alabama, United States
- Arizona Research Center - Phoenix, Arizona, United States
- Clinical Research of West Florida, Inc. (Clearwater) - Clearwater, Florida, United States
- GNP Research at Mark Jaffe, MD - Cooper City, Florida, United States
- Fortrea Clinical Research Unit - Daytona Beach, Florida, United States
- AGA Clinical Trials - Hialeah, Florida, United States
- Advanced Pharma CR, LLC - Miami, Florida, United States
- Floridian Clinical Research - Miami Lakes, Florida, United States
- Oasis Clinical Research - Las Vegas, Nevada, United States
- Universitätsklinikum Charité - Berlin, Germany