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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LY4213663

    Drug

    Administered SC

  • LY4213663

    Drug

    Administered IV

  • Placebo

    Drug

    Administered SC

  • Placebo

    Drug

    Administered IV

Treatment groups

141 Participants
are divided into 5 treatment groups
Group A: LY4213663 (Part A)Experimental treatment 1 intervention
Group B: Placebo (Part A)Placebo comparator 1 intervention
Group C: LY4213663 (Part B)Experimental treatment 1 intervention
Group D: Placebo (Part B)Placebo comparator 1 intervention
Group E: LY4213663 (Parts C and D)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Time frame
Baseline up to Week 33

Secondary outcomes

1

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663

PK: Cmax of LY4213663

Time frame
Baseline up to Week 33
2

PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663

PK: AUC of LY4213663

Time frame
Baseline up to Week 33

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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