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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
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bioavailability [ Time Frame: During dosing and for two weeks after dosing ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658749

Locations
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.
Investigators
Study Director: Mike Hodges, MD Altair Therapeutics
  More Information

No publications provided

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

Keywords provided by Altair Therapeutics, Inc.:
AIR645
Altair Therapeutics
IL4
 IL13
IL-4
IL-13

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013