Study to Assess Effect of HFO MDI Propellant on Mucociliary Clearance Compared to HFA MDI Propellant in Healthy Participants

Exclusion Criteria

• Participants are excluded from the study if any of the following criteria apply:
• 1) History of smoking > 10 pack-years, or participant quit smoking < 6 months prior to screening.
• 2) Acute or chronic upper or lower respiratory illness within 30 days of screening.
• 3) Respiratory medication or medication impacting ciliary clearance for any indication within 30 days of screening.
• 4) History of radiation exposure within the past year that would cause the participant to exceed limits for adults established by Federal Regulations.
• 5) History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
• 6) Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the IP.
• 7) History of any cancer except squamous cell and basal cell carcinomas of the skin.
• 8) Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
• 9) Any clinically significant abnormal findings in vital signs at screening, as judged by the investigator.
• 10) Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator. Note: Participants with ECG QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 480 msec will be excluded.
• 11) A SARS-CoV-2 infection in the 8 weeks prior to Visit 1, or during the Screening Period, or that required hospitalization at any time prior to Visit 1 or during the Screening Period.
• 12) Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection; eg, fever, dry cough, dyspnea, sore throat, fatigue, or laboratory-confirmed acute infection with SARS-CoV-2.
• 13) Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
• 14) History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis, alpha-1 antitrypsin, primary ciliary dyskinesia, cystic fibrosis.
• 15) Known or suspected history of drug abuse, as judged by the investigator.
• 16) Current smokers or those who have smoked or used nicotine products (including electronic cigarettes) marijuana, vaping, etc, within the 6 months prior to screening.
• 17) Positive screen for drugs of abuse or cotinine at screening.
• 18) 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 within 14 days or 5 half-lives (whichever is longer) prior to the first administration of IP.
• 19) Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (eg, > 5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages.
• 20) Using any herbal products either by inhalation or by nebulizer within 2 weeks of Visit 1, and does not agree to stop for the duration of the study.
• 21) Participation in another clinical study with an IP administered in the last 30 days or 5 half-lives, whichever is longer.
• 22) Involvement of any AstraZeneca, Labcorp, or study site employee or their close relatives.
• 23) Participants who have previously received HFO via inhalation (eg, BGF [also known as PT010, Breztri, Trixeo] HFO).
• 24) Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
• 25) Participants who cannot communicate reliably with the investigator.
• 26) Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or judicial order.
• 27) Female participants who are currently pregnant (confirmed with positive pregnancy test), breast feeding, or planned pregnancy during the study or women of childbearing potential not using acceptable contraception measures (see Inclusion Criterion).