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A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma (AIR645-CS1)

This study has been completed.
Sponsor:
Information provided by:
Altair Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00658749
First received: April 11, 2008
Last updated: June 24, 2009
Last verified: June 2009

April 11, 2008
June 24, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: During dosing and for two weeks after dosing ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: from 1st dose to 14 days after last dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00658749 on ClinicalTrials.gov Archive Site
Bioavailability [ Time Frame: During dosing and for two weeks after dosing ] [ Designated as safety issue: No ]
Plasma and sputum PK levels [ Time Frame: at various time points from pre-dose to 14 days post last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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.
  • Experimental: 1
    AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
    Intervention: Drug: AIR645
  • Placebo Comparator: 2
    Physiologic saline solution
    Intervention: Drug: Physiologic saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00658749
AIR645-CS1
No
Susan Gregory/Chief Scentific Officer, Altair Therapeutics, Inc.
Altair Therapeutics, Inc.
Not Provided
Study Director: Mike Hodges, MD Altair Therapeutics
Altair Therapeutics, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP