A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
Trial Parameters
Brief Summary
This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .
Eligibility Criteria
Key Inclusion Criteria: 1. Male and female subjects aged 18 to 65 years (inclusive) 2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia 3. Subjects must meet the criteria for non-transfusion-dependent thalassemia 4. Subjects must have a baseline hemoglobin level between 70-100 g/L(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization 5. Subjects must have evidence of iron overload during screening 6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1 7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form Key Exclusion Criteria: 1. Subjects diagnosed with alpha-thalassemia 2. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia 3. Subjects exhibit severe iron overload at the time of screening 4. In addition to