An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

Exclusion Criteria

• •Stage 1 (Healthy Volunteers)
• •History or current evidence of a clinically significant or uncontrolled disease
• •Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs.
• •History of severe allergy to milk protein
• •Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded.
• •Other criteria apply, please contact the investigator for more information
• •Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)
• •Recent history of hospitalization due to an exacerbation of airway disease within 3 months
• •Need for increased treatments of COPD within 6 weeks prior to the screening visit
• •History of and/or current diagnosis of asthma
• •Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions
• •Other criteria apply, please contact the investigator for more information