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RecruitingPhase 1

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well people handle LY4213663 and what side effects it may cause in healthy people and people with rheumatoid arthritis (RA), a disease that causes swollen, painful joints. The drug is given under the skin or into a vein, and blood tests check how it acts in the body. The study lasts about 33 weeks, not counting screening.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI) of 18 to 32. BMI is a measure of weight compared with height.
  • For Parts C and D only: Weigh at least 50 kilograms (about 110 pounds) and have a BMI of 18 to 40 at screening.
  • For Parts C and D only: Have RA that began in adulthood and was diagnosed at least 3 months before screening.

Who can't join

  • For healthy people in Parts A and B only: Have or have had a health condition that could greatly change how the body takes in, breaks down, or removes drugs.
  • For people with RA in Parts C and D only: Have Class 4 RA, the most limiting class under American College of Rheumatology rules.
  • For people with RA in Parts C and D only: Have an abnormal ECG at screening. An ECG measures the heart’s electrical activity.
  • For people with RA in Parts C and D only: Have a current or recent active infection that came on quickly.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (9)

AL

AZ

FL

NV