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

Inclusion criteria

• Healthy males and females ages 18-40
• Non-smoking
• Able to provide informed consent and agree to adhere to all study visits and requirements.
• Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
• Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion criteria

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