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)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as assessed by CTCAE v5.0
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental group
Drug:IASO-782 injection Dosage and Administration: single dose of IASO-782, 6 mg/kg or 10 mg/kg , intravenous injection at day 1
干预措施: IASO-782 injection (Drug)
Control group
Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants with adverse events as assessed by CTCAE v5.0
时间窗: up to 12 weeks
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
次要结局
未报告次要终点