Status:
COMPLETED
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
Lead Sponsor:
Altair Therapeutics, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00658749
Start Date
April 1 2008
End Date
May 1 2009
Last Update
June 25 2009
Active Locations (1)
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1
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:
San Diego, California, United States, 92130