Lead Sponsor

Sideris Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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

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