Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)

A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.

The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.

Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.

Inclusion Criteria:

• Subject's written informed consent obtained prior to any study-related procedure
• Male healthy volunteers aged 18-55 years;
• Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
• Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
• Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 1 year;
• Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
• A reliable method of contraception for the subjects and their partner.

Exclusion Criteria:

• Blood donation or blood loss less than 8 weeks before inhalation of the study medication;
• Positive HIV1 or HIV2 serology;
• Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
• History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
• Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
• Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
• Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.
• Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).