A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients

Inclusion Criteria

• •Must be between 12 and 65 years of age
• •Previously diagnosed sickle cell disease (hemoglobin electrophoresis or genotype)
• •Must have a minimum body weight of 40 kg (88 lbs) at the Screening Visit
• •Must have the ability to understand and sign written informed consent (and assent where applicable), which must be obtained prior to any study-related procedures being completed
• •All male and female patients of child bearing potential must agree to use medically accepted contraceptive regimen during study participation and for 90 days after last study drug administration
• •Must be willing to abide by all study requirements and restrictions
• •Subjects must be between 18 and 60 years of age
• •Subjects must have the ability to understand and sign written informed consent, which must be obtained prior to any study-related procedures being completed
• •Subjects must be in general good health, based upon the results of medical history, a physical examination, vital signs, laboratory profile, and a 12-lead ECG
• •All males and females of child bearing potential must agree to use medically accepted contraceptive regimen during study participation and up to 90 days after
• •Subjects must be willing to abide by all study requirements and restrictions