Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers

Exclusion Criteria

• •1. Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
• •2. Known or suspected malignancy;
• •3. Reported history of pancreatitis or gall stones;
• •4. Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
• •5. Reported family history of long QTc syndrome or a QTc of \> 450 ms at screening;
• •6. Reported history of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
• •7. Poor venous access;
• •8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening;
• •9. Donated or lost \>500 mL of blood in the previous 3 months prior to screening;
• •10. Taken an investigational drug or participated in a clinical trial within 30 days (or 5 half-lives) prior to first dose of study drug, whichever is longer;
• •11. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
• •12. Taken any prescription or non-prescription drugs and herbal medication known to be CYP450 inducers, inhibitors, and substrates within 14 days prior to screening (See Appendix B);
• •13. Taken daily Vitamin A supplement within 3 months prior to screening;
• •14. Major surgery or hospitalization within 6 months prior to screening that in the Investigators opinion would put the subject or study conduct at risk;
• •15. A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
• •16. A history of alcohol abuse according to medical history (≥ 2 drinks per day for male and ≥ 1 drink per day for female) within 9 months prior to screening;
• •17. A positive screen for alcohol, drugs of abuse at screening or admission;
• •18. An unwillingness or inability to comply with food and beverage restrictions during study participation;
• •19. Use of over-the-counter (OTC) medication within 7 days, and/or herbal medications (including herbal teas, garlic extracts) within 7 days prior to first dose of study drug;
• •20. Have a history of allergic reactions (either spontaneous or following drug administration) to ATRA or to any of the excipients or related compounds, including vitamin A;
• •21. Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.