Clinical Trial: Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Safety Investigation of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
Brief Summary: The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.
Detailed Summary:
Sponsor: Baxalta US Inc.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Baxalta US Inc.
Dates:
Date Received: September 8, 2005
Date Started: January 2003
Date Completion: October 2003
Last Updated: June 26, 2015
Last Verified: October 2006