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

This study is currently recruiting participants.
Verified by Altair Therapeutics, Inc., June 2008

Sponsored by: Altair Therapeutics, Inc.
Information provided by: Altair Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00658749
  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 I

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Sodium chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment:   80
Study Start Date:   April 2008
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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.
2: Placebo Comparator
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

Contacts
Contact: Susan Gregory, PhD     858-436-3819     sgregory@altairthera.com    
Contact: Pratik Shah, PhD     415-541-8600     pshah@tm-partners.com    

Locations
United States, California
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:     Recruiting
      San Diego, California, United States, 92130
      Contact: Susan Gregory, PhD     858-436-3819     sgregory@altairthera.com    
      Contact: Pratik Shah, PhD     415-541-8600     pshah@tm-partners.com    

Sponsors and Collaborators
Altair Therapeutics, Inc.

Investigators
Study Director:     Susan Gregory, PhD     Altair Therapeutics    
  More Information


Responsible Party:   Altair Therapeutics, Inc. ( Susan Gregory/Chief Scentific Officer )
Study ID Numbers:   AIR645-CS1
First Received:   April 11, 2008
Last Updated:   June 12, 2008
ClinicalTrials.gov Identifier:   NCT00658749
Health Authority:   Canada: Health Canada

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

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Healthy
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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