Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis

Inclusion criteria

• Healthy, male subjects aged 18 to 65 years inclusive
• Normal pulmonary function; i.e. FEV1 ≥ 80% of predicted (for age, sex, height and race) and FEV1/FVC ratio ≥ 0.7
• Subject's pre -study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator
• Subject's pre - study laboratory screen are normal or, if outside of the laboratory reference range, not considered clinically significant

Exclusion criteria

• History of any clinically relevant chronic respiratory disorder, including asthma
• Current smoker or smoked within the last 12 months
• History of significant drug or alcohol abuse (defined by the investigator). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
• Subject who has inhaled any drug in the last 30 days prior to Day 1
• Subject who has received one or more days of systemic pharmacological treatment in the 14 days immediately prior to Day 1
• Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks
• Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder