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Recruiting Phase 1 NCT07258849

A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis

Phase 1 – testing safety in a small group of people
Conditions: Healthy Rheumatoid Arthritis (RA)

Sponsor: Eli Lilly and Company

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Overview
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 participate
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
Interventions
LY4213663
DRUG
LY4213663
DRUG
Placebo
DRUG
Placebo
DRUG
Locations 9
United States (9)
Pinnacle Research Group, LLC
Anniston , Alabama
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater , Florida
NOT_YET_RECRUITING
GNP Research at Mark Jaffe, MD
Cooper City , Florida
Fortrea Clinical Research Unit
Daytona Beach , Florida
AGA Clinical Trials
Hialeah , Florida
Oasis Clinical Research
Las Vegas , Nevada
Advanced Pharma CR, LLC
Miami , Florida
Floridian Clinical Research
Miami Lakes , Florida
Arizona Research Center
Phoenix , Arizona
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
02.12.2025
Completion date
01.03.2028
Registry ID
NCT07258849
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.