Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

Exclusion Criteria

• - Pregnancy, nursing female subjects, or subjects trying to conceive
• - Clinically significant medical conditions
• - History of ECG abnormalities
• - Symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
• - Known diagnosis of glaucoma
• - Known or suspected history of substance-related disorders within 1 year of screening
• - Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period
• - Hypersensitivity to lactose or any drug or component of the formulation(s) used in this study
• - Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at screening.
• - Major surgery within four weeks or minor surgery within 2 weeks of drug administration
• - Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for study participation