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

NCT00658749 | Completed Phase 1

• 1 other identifier: AIR645-CS1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

AIR645; Altair Therapeutics; IL4; IL13; IL-4; IL-13

Outcome Measures

Primary Outcomes (1)

• 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.

  During dosing and for two weeks after dosing

Secondary Outcomes (1)

• Bioavailability

  During dosing and for two weeks after dosing

Study Arms (2)

1

EXPERIMENTAL

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

Drug: AIR645

2

PLACEBO COMPARATOR

Physiologic saline solution

Drug: Physiologic saline solution

Interventions

AIR645 DRUG

AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

1

Physiologic saline solution DRUG

Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altair Therapeutics, Inc.: lead

Study Sites (1)

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

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mike Hodges, MD

  Altair Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 25, 2009

Record last verified: 2009-06

Locations

US (1)