NCT00785668

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aerovance, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AER 001	10 mg dry powder administered using a handheld device

Timeline

• Start date: 2007-11-01
• Completion: 2008-02-01
• First posted: 2008-11-05
• Last updated: 2008-11-05

Locations

1 site across 1 country: United Kingdom