Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subject has provided written informed consent
The subject is male or female 18 to 65 years of age
If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
Non-smoker
Good general health
Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
The subject is compliant and available throughout the entire study period

Exclusion Criteria:

Current diagnosis, as per subject or investigator or screening assessment, of:

unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
history of narrow angle glaucoma
history of alcohol abuse within the past 5 years
history of smoking within the past 6 months
positive result for the alcohol and/or drugs of abuse
weight > 100 kg or < 50 kg
clinically significant abnormal ECG
history of clinically significant (per the Investigator) disease or disorder
any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results

Abnormal vital signs defined as any of the following:

Systolic blood pressure ≥ 140 mmHg
Diastolic blood pressure ≥ 90mmHg
Heart rate < 40 or > 85 beats per minute
Fever or other clinically significant physical exam findings
Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
History or current symptom(s) of respiratory tract inflammation
Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
FEV1 variability > 10% between study visits
Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
Inability to perform acceptable, quality serial spirometry or any other study procedures
Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody