Status:
COMPLETED
Phase I PK Study of Budesonide/Albuterol Delivered From PT027 in Healthy Chinese Participants.
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
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 administra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 12-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.
- In the opinion of the PI, participants who are unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
- 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.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06514157
Start Date
August 19 2024
End Date
September 9 2024
Last Update
August 26 2025
Active Locations (1)
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1
Research Site
Shanghai, China, 200031