Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

Inclusion Criteria: * Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy * Subject weighs ≥35 kg * Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study * Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1) * Cardiac T2\* score \>20 msec within 6 months before Baseline (Day 1) * Willing to use contraception during the study Exclusion Criteria: * Pregnant or breast-feeding * Serum creatinine greater than the upper limit of normal * Platelet count \<100 × 10\^9/L * Use of another investigational drug within the last 30 days * Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject