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
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 134
- Locations
- 19
- Primary Endpoint
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- 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
Arms & Interventions
LY4213663 (Part A)
Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants
Intervention: LY4213663 (Drug)
Placebo (Part A)
SAD placebo administered SC and IV
Intervention: Placebo (Drug)
LY4213663 (Part B)
Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants
Intervention: LY4213663 (Drug)
Placebo (Part B)
MAD placebo administered SC and IV
Intervention: Placebo (Drug)
LY4213663 (Parts C and D)
Multiple doses of LY4213663 administered SC and IV in participants with RA
Intervention: LY4213663 (Drug)
Outcomes
Primary Outcomes
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
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663(Baseline up to Week 33)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663(Baseline up to Week 33)