IASO-782 in Autoimmune Hematological Diseases

Официальное название

A Phase Ia Study to the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IASO-782 in Patient With Autoimmune Hematological Diseases (Autoimmune Thrombocytopenia and Warm Antibody Type Autoimmune Hemolytic Anemia)

Обзор

This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).

Подробное описание

This study is a single-dose escalation study in subjects with autoimmune hematological diseases. The study is designed to enroll subjects with autoimmune thrombocytopenia and warm antibody type immune haemolytic anaemia (ITP and wAIHA).

Referred to the clinical pharmacological study and development experience of similar drugs, one or more dose regimens will be determined for the use in Phase 1b clinical trials.

This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with autoimmune hematologic diseases (ITP and wAIHA) at the following dose levels:6mg/kg and 10mg/kg.

Вмешательства

• Препарат IASO-782 injection
  Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a dri
• Препарат placebo
  Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate

Первичные конечные точки

• Number of participants with adverse events as assessed by CTCAE v5.0 [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• Age 18-65 years
• Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA)
• Failure or relapse after at least 1 treatment for the study disease
• Stable dose of immunosuppressants for 4 weeks before screening
• Organ function or laboratory test is basically normal
• Subjects of childbearing potential and their partners must use effective contraception for at least 2 weeks before administration of investigational product, throughout the trial period, and for 28 days after the end of the trial (or early termination of the trial)
• Females of potential childbearing capacity must have a negative pregnancy test at screening
• Voluntarily participate in this study and sign the informed consent

Критерии исключения

• History of other primary malignant neoplasm within 5 years of screening
• Secondary to other disease-induced hematopoietic destruction
• Cardiac disorder within the last 3 months
• Patients with high blood pressure that cannot be controlled by drug
• Subjects with a history of allergy to any component of the investigational drug
• Active infection requiring intravenous treatment within 30 days prior to the enrollment
• Pregnant or breastfeeding women
• Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug
• Previous treatment drugs have not been adequately washed out
• ITP patients have had any previous arterial or venous thrombosis
• Patients with ITP had previous biopsy bone marrow results indicating bone marrow fibrosis (Myelofibrosis MF) ≥ 2
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
• Subjects with a history of drug abuse or mental disorder
• Other medical history or conditions that would make the subject unsuitable for the study by investigators' judge.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Institute of Hematology, Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT06534021 · IASO-782C005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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