NCT07579949尚未招募2 期
A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia
ScinnoHub Pharmaceutical Co., Ltd.8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 8
研究概览
简要总结
This study is a multicenter study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of treatment with SNH-119014 in adult participants with non-transfusion-dependent thalassemia. 30 participants with non-transfusion-dependent thalassemia were enrolled.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female;
- •≥18 years;
- •Documented diagnosis of thalassemia;
- •Non-transfusion-dependent;
- •Hb concentration ≤10.0 grams per deciliter (g/dL) during the screening period;
- •For women of reproductive potential: negative serum pregnancy test during the screening period;
- •Agreement to use approved contraceptive measures;
- •Informed consent;
排除标准
- •Hemoglobin S forms of thalassemia;
- •History of Congestive Heart Failure Within 6 months prior to signed informed consent;
- •Myocardial Infarction/unstable angina Within 6 months prior to signed informed consent;
- •Deep Vein Thrombosis/stroke/thromboembolic events Within 6 months prior to signed informed consent;
- •Poorly controlled hypertension or diabetes;
- •Markedly abnormal QTcF interval;
- •Severe arrhythmia requiring treatment as assessed by the investigator;
- •Markedly abnormal left ventricular ejection fraction;
- •Diagnosis of any other congenital or acquired hematologic disorder, or any other hemolytic process;
- •Active infection requiring intravenous antibiotics or of Grade ≥3 severity within 4 weeks prior to the first dose;
- •History of primary malignancy, except for: cured non-melanoma skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumors treated with curative intent with no known active disease and no treatment in the past 5 years;
- •History of neurological or psychiatric disorders that, in the investigator's assessment, may affect the participant's ability to participate in the clinical study;
- •Post-splenectomy sepsis;
- •Severe pulmonary disease or hepatobiliary disease;
- •Abnormal laboratory tests during screening;
- •Use of luspatercept, hydroxyurea, erythropoietin, strong CYP3A4 inhibitors, or strong CYP3A4 inducers within the prohibited period specified in the protocol;
- •Receipt of anticoagulant therapy prior to screening, or requirement for anticoagulant therapy during the study period;
- •Prior bone marrow or stem cell transplant;
- •Pregnant or lactating women;
- •Major surgery within 6 months prior to signing informed consent or planned during the study period;
- •Splenectomy scheduled during the study treatment period;
- •Participation in another clinical trial and receipt of investigational treatment within 3 months;
- •History of severe allergy, or allergy to SNH-119014 or its excipients;
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
研究者
研究点 (8)
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