Health Trials

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

ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

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.

Eligibility criteria

Qualifiers

Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive

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

Disqualifiers

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

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

Trial design

Treatments tested in this trial

  • LY4213663
  • LY4213663
  • Placebo
  • Placebo

Treatment groups

141 Participants
are divided into 5 treatment groups

Locations

10
Germany
Universitätsklinikum Charité10117, Berlin Germany
United States
Pinnacle Research Group, LLC36207, AnnistonAlabama, United States
Arizona Research Center85053, PhoenixArizona, United States
Clinical Research of West Florida, Inc. (Clearwater)33765, ClearwaterFlorida, United States

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov