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Recruiting NCT07258849

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

Phase I Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4213663, LY4213663, Placebo, Placebo.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

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.

Interventions

  • Drug LY4213663
    Administered SC
  • Drug LY4213663
    Administered IV
  • Drug Placebo
    Administered SC
  • Drug Placebo
    Administered IV

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663 [Time frame: Baseline up to Week 33]
  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663 [Time frame: Baseline up to Week 33]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 9 centers
  • Pinnacle Research Group, LLC — Anniston
  • Arizona Research Center — Phoenix
  • Clinical Research of West Florida, Inc. (Clearwater) — Clearwater
  • GNP Research at Mark Jaffe, MD — Cooper City
  • Fortrea Clinical Research Unit — Daytona Beach
  • AGA Clinical Trials — Hialeah
  • Advanced Pharma CR, LLC — Miami
  • Floridian Clinical Research — Miami Lakes
  • … and 1 more center
Germany · 1 center
  • Universitätsklinikum Charité — Berlin

Identifiers

NCT: NCT07258849 · 27749 · 2025-523980-39-00 · J6T-MC-KYAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗