A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Non-transfusion-dependent β- Thalassemia
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 must have evidence of iron overload during screening
• Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
• Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form