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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: AIR645; Drug: Physiologic saline solution

• Registration Number: NCT00658749
• Lead Sponsor: Altair Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-24
• Last Update Posted: 2009-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AIR645	AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
2	Physiologic saline solution	Physiologic saline solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bioavailability	During dosing and for two weeks after dosing

Trial Locations

Locations (1)

Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in: 🇺🇸 San Diego, California, United States