4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee. Liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) and serum bilirubin (total and direct) must be ≤ the upper limit of normal at screening for inclusion. Platelets, hemoglobin and hematocrit must be ≥ than the lower limit of normal at screening for inclusion.