The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

Inclusion criteria

• Healthy adult male smokers between 18 and 65 years of age with signed informed consent

Exclusion criteria

• Serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, D-1 and 6
• Cholesterol level ≥ 240 mg/dL
• Hypertension (blood pressure SBP > 140, DBP > 90 mmHg)
• Body mass index < 18 or > 32 kg/m2,
• Creatinine clearance calculated by the Cockcroft and Gault method calculated to be < 90 mL/min,
• Additional laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening
• Clinically significant abnormalities on physical examination,
• History or evidence of renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) system dysfunction,
• History of seizures or history of epilepsy,
• History of serious (Principal Investigator judgment) mental illness,
• Receipt of investigational medicinal product within 30 days prior to the planned date of study drug administration,
• Positive serology for human immunodeficiency virus type 1 or 2, or hepatitis B surface antigen,
• Fever > 37.5°C at the time of planned dosing,
• Suspicion, or recent history, of alcohol or substance abuse,
• Donated blood or blood products within the past 30 days,
• Employee or family member of the investigational site,
• Subjects who are either unwilling to agree to refrain from use or found to be using Nicotine (or nicotine products) including cigarettes from 12 hours prior to start of each study drug infusion through to the completion of endothelial function testing, Alcohol, Caffeine, Xanthine-containing food or beverages and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement periods, Supplementary antioxidant vitamins from 7 days prior to dosing and throughout the confinement periods, Prescription medications from 14 days prior to and 7 days post treatment
• Subjects having previous exposure to Bendavia.