Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-28 @ 6:16 PM
Study NCT ID:
NCT00785668
Status:
COMPLETED
Last Update Posted:
2008-11-05
First Post:
2008-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects
Sponsor:
Aerovance, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: