Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017

Exclusion Criteria

• •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
• •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 SV.
• •Occurrence of a COPD exacerbation, which is not resolved by 4 weeks or more prior to the SV/informed consent. (Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment other than rescue albuterol or the patient's regular maintenance therapy. This includes requiring the use of systemic corticosteroids, antibiotics, and/or emergency room visit or hospitalization.)
• •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. A patient who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant noncystic bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Allergic rhinitis is not exclusionary.
• •Other criteria apply, please contact the investigator for more information