Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

Exclusion Criteria

• •1. Allergy to study medication
• •2. Pregnant or breast feeding
• •3. Received investigational medicine (IMP) within past 30 days
• •4. VO2 max \< 35 mL/kg/min (male), \< 30 mL/kg/min (female) at screening
• •5. Abnormal pulmonary function testing at screening
• •6. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
• •7. History of ongoing alcohol or substance abuse
• •8. Known cardiovascular disease, including treated or untreated hypertension
• •9. Respiratory disease and/or any other significant medical condition, including psychiatric disorders
• •10. Clinically significant abnormality on ECG per PI discretion
• •11. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
• •12. Plasma donation within 7 days prior to screening
• •13. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
• •14. History of smoking
• •15. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
• •16. History of seizures
• •17. Previous pneumothorax or pneumomediastinum
• •18. Hypo/Hyperglycemia
• •19. Diabetes
• •20. Regularly taking medications which may alter heart rate, blood pressure or cardiac output
• •21. Previous history of middle ear equalization problems at discretion of PI