A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Asthma Clinical Trial

— AIR645-CS1  

Official title:

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658749
• Other study ID #: AIR645-CS1
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2008
• Last updated: June 24, 2009
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Altair Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria*:

• Good General Health (with or without allergic rhinitis and/or controlled asthma)

• Non-smoker for at least 2 years

• Normal lung function (DLCO)

• Able to provide informed consent and to understand and comply with the requirements of the study

Exclusion Criteria*:

• Clinically significant medical history or condition which precludes participation

• Clinically significant ECG abnormality

• Clinically significant VS or PE abnormality

• Clinically significant screening lab abnormality

• Abnormal lung function (FEV1 <80% predicted)

• Respiratory infection within 14 days of randomization

• HBV, HCV, or HIV

• Breastfeeding or pregnant female

• History of alcohol abuse or illicit drug use within past 24 months

• Use of any tobacco or nicotine-containing product within past 6 months

• Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol

• Use of any investigational drug within past 30 days

• Use of any investigational monoclonal antibody or recombinant protein within past 90 days

• Donation of plasma within past 7 days

• Donation or loss of whole blood within past 56 days

• Simplified list of I/E criteria; unabridged list available upon request.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AIR645
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
• Physiologic saline solution
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Locations

Country	Name	City	State
United States	Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Altair Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests.		During dosing and for two weeks after dosing	Yes
Secondary	Bioavailability		During dosing and for two weeks after dosing	No