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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4213663 (Part A) 		Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants
  • Drug: LY4213663
    Administered SC
  • Drug: LY4213663
    Administered IV
Placebo Comparator
Placebo (Part A) 		SAD placebo administered SC and IV
  • Drug: Placebo
    Administered SC
  • Drug: Placebo
    Administered IV
Experimental
LY4213663 (Part B) 		Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants
  • Drug: LY4213663
    Administered SC
  • Drug: LY4213663
    Administered IV
Placebo Comparator
Placebo (Part B) 		MAD placebo administered SC and IV
  • Drug: Placebo
    Administered SC
  • Drug: Placebo
    Administered IV
Experimental
LY4213663 (Parts C and D) 		Multiple doses of LY4213663 administered SC and IV in participants with RA
  • Drug: LY4213663
    Administered SC
  • Drug: LY4213663
    Administered IV

Recruiting Locations

Pinnacle Research Group, LLC
Anniston, Alabama 36207
Contact:
256-236-0055, ext 101

Arizona Research Center
Phoenix, Arizona 85053
Contact:
602-773-3020

Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida 33765
Contact:
727-466-0078

GNP Research at Mark Jaffe, MD
Cooper City, Florida 33024
Contact:
754-248-3589

Fortrea Clinical Research Unit
Daytona Beach, Florida 32117
Contact:
866-429-3700

AGA Clinical Trials
Hialeah, Florida 33012
Contact:
704-526-6864

Advanced Pharma CR, LLC
Miami, Florida 33417
Contact:
305-220-2727, Ext 802

Floridian Clinical Research
Miami Lakes, Florida 33016
Contact:
305-330-9977

Oasis Clinical Research
Las Vegas, Nevada 89121
Contact:
702-832-1369

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.