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

NCT06514157 | Completed Phase 1

• 1 other identifier: D6935C00001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Chinese healthy volunteer; Phase I

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Incidence of AEs/SAEs

  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

  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

  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.

  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

  Screening (Day -27 to Day -2), Day -1, Follow-up (Day 3 to Day 7)

Study Arms (1)

BDA MDI

EXPERIMENTAL

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)

Interventions

budesonide/albuterol sulfate metered dose inhaleor (BDA MDI) COMBINATION_PRODUCT

BDA MDI 160 μg/180 μg (single dose administered as 2 actuations of 80 μg/90 μg)

BDA MDI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Chinese participants who are healthy
• Body weight ≥ 45 kg for female participants and ≥ 50 kg for male participants and body BMI ≤ 26 kg/m2 at Visit 1 (screening).
• Male and non-pregnant, non-lactating female.
• Provision of signed and dated, written informed consent prior to any study specific procedures.
• 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.
• Non-smoker.
• 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.

You may not qualify if:

• As judged by the investigator, any evidence which in the investigator's opinion makes it undesirable for the participant to participate in the study.
• History of any significant drug allergy or hypersensitivity to albuterol sulfate or other beta-adrenergic agonists or to budesonide or other corticosteroids.
• 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.
• Have any gastrointestinal, hepatic, or renal condition that might affect the absorption, distribution, biotransformation, or excretion of drugs.
• 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.
• 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.
• 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.
• 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.
• lead ECG showing QTcF ≥ 450 msec for participants as indicated in the reading report assessed at Visit 1 (screening).
• Positive test results for syphilis antibody, HBsAg, hepatitis C antibody and/or HIV I antibodies at Visit 1 (screening).
• Have a history of alcohol or substance abuse within the previous 5 years as reported by the participant.
• Positive results for drugs of abuse at Visit 1 (screening) or Day -1 at Visit 2.
• 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).
• Inability to be venipunctured or tolerate venous access as determined by the PI or designee.
• Participants unable to give their consent, or participants of consenting age but under guardianship, or vulnerable participants.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Shanghai, 200031, China

Location

Related Links

• D6935C00001\_CSR Synopsis\_Redacted

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 23, 2024
• Study Start: August 19, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

CN (1)