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Предстои набиране Фаза 1 NCT07284797

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Idiopathic Inflammatory Myopathy (IIM)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy Idiopathic Inflammatory Myopathies

Спонсор: Xencor, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with IIM. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
Описание
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb657 in healthy adult participants and participants with IIM.
Кой може да участва
Inclusion Criteria: Healthy participants - Adult participants in good health Idiopathic inflammatory myopathy participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) classification of Idiopathic inflammatory myopathy Idiopathic inflammatory myopathy participants - Stable doses of Idiopathic inflammatory myopathy medications prior to screening All participants - Use of highly effective methods of contraception Exclusion Criteria: * Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * Recurrent infections or active clinically significant infection * Active or untreated latent tuberculosis * Cancer or history of cancer or lymphoproliferative disease within the previous 5 years * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
Места на провеждане 1
Австралия (1)
Xencor Investigative Site
Melbourne
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
01.02.2026
Крайна дата
01.02.2027
Регистрационен номер
NCT07284797
Източник
anzctr
Запитване за медицински туризъм

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