Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations

Inclusion Criteria

• •1. Provide written informed consent prior to any study procedures.
• •2. Age 18 to 60 and able to read and write English
• •3. Females must be of non-childbearing potential. Evidence of non-childbearing potential includes documented surgical sterilization (hysterectomy or bilateral oophorectomy) or being postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological cause. In addition, women must have a documented serum follicle stimulating hormone (FSH) level \>40 mIU/mL.
• •4. Light smokers (\<10 cigarettes per day), non-smokers, or ex-smokers
• •5. Body mass index ≥18.5 and \<30 kg/m2
• •6. Able to take oral medications and willing to adhere to medication regimen during the study
• •7. No clinically relevant abnormal physical findings at the Screening examination
• •8. Electrocardiogram without clinically significant abnormality at Screening
• •9. Normal blood pressure (BP) and heart rate (systolic BP 90 to 140 mmHg; diastolic BP 50 to 90 mmHg; heart rate 50 to 100 beats per minute)
• •10. No clinically relevant abnormal laboratory findings (general biochemistry, hematology, urinalysis, endocrinology \[cortisol\]) at Screening
• •11. Adequate organ function at screening as defined by:
• •1. Serum aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN; unless the increased AST is assessed by the Investigator as due to hemolysis and/or hepatic iron deposition); and alanine aminotransferase (ALT) ≤ 2.5 × ULN (unless the increased ALT is assessed by the Investigator as due to hepatic iron deposition).
• •2. Normal or elevated levels of serum bilirubin. Serum bilirubin \>2× ULN is acceptable if the elevation is attributed to hemolysis with or without Gilbert's syndrome.
• •3. Serum creatinine ≤ 1.25 × ULN. If serum creatinine \> 1.25 × ULN, then 24-hour measured or calculated (Cockcroft-Gault) glomerular filtration rate ≥ 60 mL/min.
• •4. Absolute neutrophil count (ANC) ≥ 1.2 × 109/L.
• •5. Platelet count ≥ 100 × 109/L.
• •6. Activated partial thromboplastin time (aPTT) and international normalized ratio ≤ 1.25 × ULN, unless the patient is receiving therapeutic anticoagulants.