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

Inclusion Criteria:

Stage 1 (Healthy Volunteers)

- Male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body
mass index (BMI) of less than 30 kg/m^2.

- In good health as determined by medical and psychiatric history, physical
examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and
serology.

- Other criteria apply, please contact the investigator for more information

Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)

- Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg

- Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack
years at the screening visit

- Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung
Disease guidelines.

- Other criteria apply, please contact the investigator for more information

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