Phase I PK Study of Budesonide/Albuterol Delivered From PT027 in Healthy Chinese Participants. (PUTUO)

A Phase I, Open-Label, Single-dose, Single Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Budesonide and Albuterol Delivered by PT027 in Healthy Chinese Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Combination product: budesonide/albuterol sulfate metered dose inhaleor (BDA MDI)

Detailed Description

This is a Phase I, single centre, single arm, open-label study to gather information on the PK, safety, and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese male and female participants. Approximately 14 healthy Chinese participants, aged 18 to 55 years, will be assigned to study intervention.

The study will comprise:

A screening period of minimum 2 days and maximum 27 days Inpatient admission period during which participants will be resident from the day prior to administration of BDA MDI (Day -1) until at least 24 hours after dosing. Participants will be discharged on the morning of Day 2. The treatment will consist of a single dose of BDA MDI 160 μg/180 μg (administered as 2 actuations of 80 μg/90 μg) followed by 24 hours of plasma sampling for determination of PK parameters A Follow-up Visit within 3 to 7 days after the administration of BDA MDI.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200031
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Chinese participants who are healthy
3. Body weight ≥ 45 kg for female participants and ≥ 50 kg for male participants and body BMI ≤ 26 kg/m2 at Visit 1 (screening).
4. Male and non-pregnant, non-lactating female.
5. Provision of signed and dated, written informed consent prior to any study specific procedures.
6. Resting heart rate ≥ 50 beats per minute (bpm) and ≤ 100 bpm at Visit 1 (screening) and at admission to the unit on Day -1 at Visit 2.
7. Non-smoker.
8. Must be able to demonstrate proper inhalation technique using the Vitalograph AIM device 3 repeated times as well as be able to use the BDA MDI according to instructions at Visit 1 (screening) and Day -1.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BDA MDI; Each randomized participant will receive a single dose of BDA MDI 160 μg/180 μg (administered as 2 actuations of 80 μg/90 μg) on Day 1 in the morning.	Combination product: budesonide/albuterol sulfate metered dose inhaleor (BDA MDI); BDA MDI 160 μg/180 μg (single dose administered as 2 actuations of 80 μg/90 μg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• D6935C00001_CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Phase I; Chinese healthy volunteer
• Additional Relevant MeSH Terms: Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: D6935C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No