Phase I PK study of budesonide/albuterol delivered from PT027 in healthy Chinese participants. - PUTUO

Exclusion Criteria

• 1 As judged by the investigator, any evidence which in the investigator’s opinion makes it undesirable for the participant to participate in the study.
• 2 History of any significant drug allergy or hypersensitivity to albuterol sulfate or other beta-adrenergic agonists or to budesonide or other corticosteroids.
• 3 Recent history of a disease or condition that would result in any residual upper respiratory airways/lung inflammatory process or residual limited lung function at the time of Day 1 at Visit 2.
• 4 Have any gastrointestinal, hepatic, or renal condition that might affect the absorption, distribution, biotransformation, or excretion of drugs.
• 5 Use of any medication within 2 weeks or within the equivalent time of 5 half-lives of taking the last dose (whichever is longer) before the study intervention, or hormonal drug products and traditional Chinese medicines within 30 days before the study intervention.
• 6 Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days or 5 half-lives of the drugs (whichever takes longer) of Day 1 at Visit 2.
• 7 Have abnormal and clinically significant results on the physical examination, medical history, clinical chemistry, haematology, or urinalysis at Visit 1 (screening) or Day -1 at Visit 2.
• 8 Resting systolic blood pressure ≥ 140 or ≤ 90 mmHg and resting diastolic blood pressure ≥ 90 or ≤ 50 mmHg at Visit 1 (Screening) or Day -1 at Visit 2.
• 9 12-lead ECG showing QTcF ≥ 450 msec for participants as indicated in the reading report assessed at Visit 1 (screening).
• 10 Positive test results for syphilis antibody, HBsAg, hepatitis C antibody and/or HIV I antibodies at Visit 1 (screening).
• 11 Have a history of alcohol or substance abuse within the previous 5 years as reported by the participant.
• 12 Positive results for drugs of abuse at Visit 1 (screening) or Day -1 at Visit 2.
• 13 Have participated in a blood/plasma donation or blood loss greater than 400 mL within 90 days, or greater than 200 mL within 30 days prior to screening (Visit 1).
• 14 Inability to be venipunctured or tolerate venous access as determined by the PI or designee.
• 15 Participants unable to give their consent, or participants of consenting age but under guardianship, or vulnerable participants.
• 16 In the opinion of the PI, participants who are unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
• 17 Participants who are relatives of the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or directly involved in the conduct of the study.