A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects

Asthma Clinical Trial

Official title: A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects

Status Completed

Clinical Trial Summary

This is a single centre, single dose pharmacokinetic/safety study in male and female asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a dry powder using a handheld device. The goals of this study are to understand the pharmacokinetics and safety of AER 001 administered as a dry powder in mild to moderate asthmatics.

Clinical Trial Description

Study Design

• Single centre, single dose PK/safety study in male and female asthmatic subjects.

• Approximately 10 subjects will be dosed.

• Treatments will be administered by dry powder inhalation using a handheld device

• Subjects will attend the Unit for screening and if eligible return to the Unit on the day of dosing (Day 1). Subjects will be required to stay overnight in the Unit and will be discharged on Day 2.

• On study Day 1, subjects are to receive a single administration of AER 001. N.B. Screening will take place within 28 days prior to administration of AER 001.

Primary objective: To investigate the pharmacokinetics of AER 001 administered as a dry powder in mild to moderate asthmatics.

Secondary objective: To investigate the safety of AER 001 administered as a dry powder in mild to moderate asthmatics. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00785668
• Study type: Interventional
• Source: Aerovance, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Completion date: February 2008