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

Tracking Information

First Received Date ^ICMJE

April 11, 2008

Last Updated Date

June 24, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Adverse events [ Time Frame: from 1st dose to 14 days after last dose ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00658749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00658749

Other Study ID Numbers ^ICMJE

AIR645-CS1

Has Data Monitoring Committee

Responsible Party

Susan Gregory/Chief Scentific Officer, Altair Therapeutics, Inc.

Study Sponsor ^ICMJE

Altair Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Mike Hodges, MD

Altair Therapeutics

Information Provided By

Altair Therapeutics, Inc.

Verification Date

June 2009

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

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