A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Thalassemia

In brief

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.

Key facts

Study ID

NCT07579949

Run by

ScinnoHub Pharmaceutical Co., Ltd.

People needed

30

Starts

2026-06-18

Expected to finish

2027-04-29

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Foshan First People's Hospital — Foshan, Guangdong, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• Maoming People's Hospital — Maoming, Guangdong, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, China
• 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of China — Nanning, Guangxi, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hunan, China
• Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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