NCT06514157

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-08-19
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2024-07-23
• Last updated: 2025-08-26

Locations

1 site across 1 country: China