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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Altair Therapeutics, Inc.
• Treatments: Pharmaceutical Solutions

Criteria

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.