A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) with a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

Exclusion Criteria

• - History or current evidence of any clinically significant disease or disorder, including endocrinological diseases, such as thyrotoxicosis, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results through participation in the study.
• - Participants who have previously received BGF MDI HFO.
• - History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane.
• - History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• - Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
• - History of narrow angle glaucoma or change in vision that may be relevant.
• - History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, which in the opinion of the investigator, is clinically significant.
• - Unresectable cancer that has not been in complete remission for at least 5 years.
• - Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
• - Any clinically significant abnormal findings in physical examination or vital signs at screening, as judged by the investigator.
• - Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator.
• - Any positive result on screening for serum hepatitis B surface antigen or anti-hepatitis B core antibody, indicative of hepatitis B, hepatitis C antibody, or human immunodeficiency virus.
• - Positive reverse transcription polymerase chain reaction test for SARS-CoV-2 prior to randomization.
• - Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
• - Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, or mechanically ventilated).
• - Recent (within 14 days prior to admission to the Clinical Unit) exposure to someone who has COVID-19 symptoms or tested positive for SARS-CoV-2.
• - History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
• - Known or suspected history of drug abuse.
• - Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
• - Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
• - Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
• - Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• - Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate).