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

ClinicalTrials.gov ID

NCT07579949

Lead Sponsor

ScinnoHub Pharmaceutical Co., Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

30Estimated

Last Update Posted

May 12, 2026Actual

Start Date

Jun 18, 2026Estimated

Primary Completion Date

Mar 29, 2027Estimated

Completion Date

Apr 29, 2027Estimated

Official Title

A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia

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.

• Thalassemia

• SNH-119014 dose 1
• SNH-119014 dose 2
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

ScinnoHub Pharmaceutical Co., Ltd.INDUSTRY

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