Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

Exclusion Criteria

• •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
• •Acute disease state within 7 days before study day 1.
• •History of drug abuse within 1 year before study day 1.
• •History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
• •Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
• •Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
• •History of any clinically important drug allergy.
• •Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
• •Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
• •Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
• •Donation of blood (i.e. 450 ml) within 90 days before study day 1.