NCT05148312

Single-dose AQ001S PK Study in Healthy Volunteers

A Randomized, Open Label, Single-center, Single-dose, Four-period Crossover Clinical Trial to Assess the PK Profile and Safety of Budesonide Inhalation Solution AQ001S Compared to Budesonide Inhalation Suspension in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Aquilon Pharmaceuticals S.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.

Detailed description

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml. Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization. The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution. The primary safety objective is to assess the safety of AQ001S inhalation solution.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Budesonide Inhalant Product	Single-dose of budesonide solution administered by nebulization.

Timeline

• Start date: 2021-11-12
• Primary completion: 2021-12-24
• Completion: 2022-02-21
• First posted: 2021-12-08
• Last updated: 2022-11-03

Locations

1 site across 1 country: Bulgaria