|
|
|
|
|
|
Sponsored by: |
Altair Therapeutics, Inc. |
Information provided by: | Altair Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00658749 |
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 |
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 |
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.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria*:
Exclusion Criteria*:
Donation or loss of whole blood within past 56 days
Contact: Susan Gregory, PhD | 858-436-3819 | sgregory@altairthera.com |
Contact: Pratik Shah, PhD | 415-541-8600 | pshah@tm-partners.com |
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 |
Altair Therapeutics, Inc. |
Study Director: | Susan Gregory, PhD | Altair Therapeutics |
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 |
|
|
|
|
|