NCT07579949Not yet recruitingPhase 2
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 sites in 1 country30 target enrollmentStarted: June 18, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 8
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Investigators
Study Sites (8)
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