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

May 6, 2026 updated by: ScinnoHub Pharmaceutical Co., Ltd.

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cohort 3
Placebo
Drug: Placebo
Placebo
Experimental: Cohort 1
Study Drug
Drug: SNH-119014 dose 1
Study Drug
Experimental: Cohort 2
Study Drug
Drug: SNH-119014 dose 2
Study Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: From signing the informed consent to 4 weeks after the last dose
The incidence of Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events
From signing the informed consent to 4 weeks after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ScinnoHub Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 18, 2026

Primary Completion (Estimated)

March 29, 2027

Study Completion (Estimated)

April 29, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNH-119014-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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