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 .
Male and female subjects aged 18 to 65 years (inclusive)
Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
Subjects must meet the criteria for non-transfusion-dependent thalassemia
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
Subjects diagnosed with alpha-thalassemia
Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
Subjects exhibit severe iron overload at the time of screening
In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes