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Набира участници Фаза 1 NCT07258849

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy Rheumatoid Arthritis (RA)

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
LY4213663
DRUG
LY4213663
DRUG
Placebo
DRUG
Placebo
DRUG
Места на провеждане 9
САЩ (9)
Pinnacle Research Group, LLC
Anniston , Alabama
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater , Florida
NOT_YET_RECRUITING
GNP Research at Mark Jaffe, MD
Cooper City , Florida
Fortrea Clinical Research Unit
Daytona Beach , Florida
AGA Clinical Trials
Hialeah , Florida
Oasis Clinical Research
Las Vegas , Nevada
Advanced Pharma CR, LLC
Miami , Florida
Floridian Clinical Research
Miami Lakes , Florida
Arizona Research Center
Phoenix , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
02.12.2025
Крайна дата
01.03.2028
Регистрационен номер
NCT07258849
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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