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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.
Information provided by:
Altair Therapeutics, Inc. Identifier:
First received: April 11, 2008
Last updated: June 24, 2009
Last verified: June 2009
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.

Condition Intervention Phase
Drug: AIR645
Drug: Physiologic saline solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Further study details as provided by Altair Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Bioavailability [ Time Frame: During dosing and for two weeks after dosing ]

Enrollment: 80
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Drug: AIR645
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Placebo Comparator: 2
Physiologic saline solution
Drug: Physiologic saline solution
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00658749

United States, California
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:
San Diego, California, United States, 92130
Sponsors and Collaborators
Altair Therapeutics, Inc.
Study Director: Mike Hodges, MD Altair Therapeutics
  More Information

Responsible Party: Susan Gregory/Chief Scentific Officer, Altair Therapeutics, Inc. Identifier: NCT00658749     History of Changes
Other Study ID Numbers: AIR645-CS1
Study First Received: April 11, 2008
Last Updated: June 24, 2009

Keywords provided by Altair Therapeutics, Inc.:
Altair Therapeutics

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions processed this record on May 22, 2017