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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIR645
Physiologic saline solution
Sponsored by
Altair Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)

Physiologic saline solution

Outcomes

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.

Secondary Outcome Measures

Bioavailability

Full Information

First Posted
April 11, 2008
Last Updated
June 24, 2009
Sponsor
Altair Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00658749
Brief Title
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
Acronym
AIR645-CS1
Official Title
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Altair Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Physiologic saline solution
Intervention Type
Drug
Intervention Name(s)
AIR645
Intervention Description
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Intervention Type
Drug
Intervention Name(s)
Physiologic saline solution
Intervention Description
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Bioavailability
Time Frame
During dosing and for two weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Hodges, MD
Organizational Affiliation
Altair Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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