Trial | NCT00658749  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
Study Started
Apr 30
2008
Primary Completion
Apr 30
2009
Study Completion
May 31
2009
Last Update
Jun 25
2009
Estimate

Drug AIR645

AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Drug Physiologic saline solution

Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

1 Experimental

AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)

2 Placebo Comparator

Physiologic saline solution

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.
No Results Posted