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RECRUITINGPhase 1INTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

LY4213663

Administered SC

DRUG

LY4213663

Administered IV

DRUG

Placebo

Administered SC

DRUG

Placebo

Administered IV

Locations (9)

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