Dose-Escalation Study of SCD-101 in Sickle Cell Disease

Exclusion Criteria

• •1. Red blood cell transfusion within 3 months of enrollment
• •2. Hydroxyurea treatment within 6 months of enrollment
• •3. Painful or other acute sickle cell event that required a hospitalization within 4-weeks of enrollment
• •4. AST and/or ALT \>3x upper limit of normal and/or creatinine \>2x upper limit of normal or any other significant renal or hepatic impairment
• •5. Estimated creatinine clearance (CrCl) \< 60 mL/min (Cockcroft- Gault formula) at screening.
• •6. QTc interval of \>470 msec at trial entry and participant with congenital long QT syndrome.
• •7. No other significant sickle cell or non-sickle cell illness that would confound the results of the trial
• •8. Any condition that, in the view of the investigator, places the participant at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial
• •9. Participant pregnant or nursing an infant or planning pregnancy during the course of the trial
• •10. History of allergic reactions attributed to sorghum or compounds of similar chemical or biologic composition (such as Nicosan, Niprisan, Jobelyn or Xickle).
• •11. Other investigational drug use within 3 months of enrollment
• •12. PROMIS Fatigue Questionnaire 8a T-score ˂ 44.3