Phase I PK Study of Budesonide/Albuterol Delivered From PT027 in Healthy Chinese Participants.
NCT Number: NCT06514157
Acronym: PUTUO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteer
Interventions: COMBINATION_PRODUCT: budesonide/albuterol sulfate metered dose inhaleor (BDA MDI)
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2024-11-27
Locations: Research Site, Shanghai, 200031, China

Summary:
A phase I study to assess the PK, safety, and tolerability of budesonide and albuterol delivered from a single dose of BDA MDI administered by inhalation in healthy Chinese participants.

Primary Outcome Measures: AUClast of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|AUCinf of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|Cmax of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|tmax of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|Tlast of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|t½λz of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|CL/F of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose|Vz/F of budesonide and albuterol, To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration, From Day 1 pre-dose to 24 hours post dose
Secondary Outcome Measures: Incidence of AEs/SAEs, To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening(Day-27 to Day-2), Day-1, Day1(dosing day), Day 2, Follow-Up(Day 3 to Day7)|Incidence of abnormal vital signs: blood pressure and pulse rate, To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening(Day-27 to Day-2), Day-1, Day1(post dose), Day 2, Follow-Up(Day 3 to Day7)|Incidence of abnormal haematology assessments: WBC count, RBC count, Hemoglobin, Platelets and Leukocytes absolute count, To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening (Day -27 to Day -2), Day -1, Follow-up (Day 3 to Day 7)|Incidence of abnormal 12-lead ECG parameters: heart rate, RR interval, QRS interval, PR interval, QT/QTcF interval., To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening (Day -27 to Day -2), Day 1(post dose), Follow-up (Day 3 to Day 7)|Incidence of abnormal clinical chemistry assessments： Sodium, potassium, calcium, urea, creatinine, ALP, ALT, AST, total bilirubin, CK albumin and fasting glucose, To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening (Day -27 to Day -2), Day -1, Follow-up (Day 3 to Day 7)|Incidence of abnormal urinalysis： Glucose, blood, protein, microscopy(including RBC,WBC and casts), To assess the safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese participants, Screening (Day -27 to Day -2), Day -1, Follow-up (Day 3 to Day 7)