Overview

Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency

Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Baxalta now part of Shire
Baxalta US Inc.
Collaborator:
Arriva Pharmaceuticals, Inc.
Treatments:
Alpha 1-Antitrypsin
Protein C Inhibitor