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

ConditionThalassemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorScinnoHub Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female;

Documented diagnosis of thalassemia;

Non-transfusion-dependent;

Hb concentration ≤10.0 grams per deciliter (g/dL) during the screening period;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SNH-119014 dose 1

    Drug

    Study Drug

  • SNH-119014 dose 2

    Drug

    Study Drug

  • Placebo

    Drug

    Placebo

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety evaluation

The incidence of Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events

Time frame
From signing the informed consent to 4 weeks after the last dose

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: