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