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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07258849
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • LY4213663 — DRUG
    Administered SC
  • LY4213663 — DRUG
    Administered IV
  • Placebo — DRUG
    Administered SC
  • Placebo — DRUG
    Administered IV

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Week 33 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207
256-236-0055, ext 101
Vishala Chindalore (PRINCIPAL_INVESTIGATOR)
Arizona Research CenterPhoenixArizona85053
602-773-3020
Louise Taber (PRINCIPAL_INVESTIGATOR)
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765
727-466-0078
Robert Levin (PRINCIPAL_INVESTIGATOR)
GNP Research at Mark Jaffe, MDCooper CityFlorida33024
754-248-3589
Mark Jaffe (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitDaytona BeachFlorida32117
866-429-3700
Sharrell Cooper (PRINCIPAL_INVESTIGATOR)
AGA Clinical TrialsHialeahFlorida33012
704-526-6864
Wilson Cueva (PRINCIPAL_INVESTIGATOR)
Advanced Pharma CR, LLCMiamiFlorida33417
305-220-2727, Ext 802
Simon Abelson (PRINCIPAL_INVESTIGATOR)
Floridian Clinical ResearchMiami LakesFlorida33016
305-330-9977
Christopher Mesa (PRINCIPAL_INVESTIGATOR)
Oasis Clinical ResearchLas VegasNevada89121
702-832-1369
Stephen Tam (PRINCIPAL_INVESTIGATOR)

Find similar trials in Anniston, AL

By research site
Pinnacle Research Group, LLC· Anniston, ALArizona Research Center· Phoenix, AZClinical Research of West Florida, Inc. (Clearwater)· Clearwater, FLGNP Research at Mark Jaffe, MD· Cooper City, FLFortrea Clinical Research Unit· Daytona Beach, FLAGA Clinical Trials· Hialeah, FL

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