Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

Inclusion Criteria: * Male and non-pregnant female patients 16-70 years of age (inclusive) * Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) \[performed locally\]. All sickle cell disease genotypes are eligible. * Experienced at least 1 VOC within the preceding 12 months prior to Screening, as determined by medical history. * If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening * Hemoglobin ≥4.0 g/dL. Absolute neutrophil count ≥1.0 x 109/L and platelet count ≥75 x 109/L * Adequate renal and hepatic function as defined: * GFR ≥45 mL/min/1.73 m2 calculated by CKD-EPI * ALT ≤3 x ULN * Direct (conjugated) bilirubin ≤2 x ULN * ECOG performance status ≤2 * Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures Exclusion Criteria: * History of stem cell transplant. * Acute VOC ending 7 days prior to first dosing * Ongoing hospitalization prior to Screening * Received blood products within 30 days to first dosing * Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) * History of severe hypersensitivity reactions to other monoclonal antibodies * Received a monoclonal antibody or immunoglobulin -based agent within 1 year of Screening, or has documented immunogenicity to a prior biologic. * Received active treatment on anothe…