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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
141 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for healthy adults and adults with rheumatoid arthritis. Participants will take a study drug and have their blood tested to see how their body responds to it over about 33 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index (BMI) of 18.0 to 32.0 kg/m²
I weigh at least 50 kilograms and have a BMI between 18.0 and 40.0 kg/m²
I have been diagnosed with adult-onset rheumatoid arthritis for at least 3 months
You may not be able to join if
I have a history of serious heart, lung, liver, kidney, or mental health issues
I have Class 4 rheumatoid arthritis
I have an abnormal electrocardiogram (ECG) at screening
I have a current or recent active infection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 th…
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.
Trial Locations
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Status
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 mo…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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