NCT00161707

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

Phase I Safety Investigation of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alpha1-antitrypsin Deficiency

Interventions

Type	Name	Description
DRUG	Aerosolized, Recombinant Alpha 1-Antitrypsin

Timeline

• Start date: 2003-01-07
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2005-09-13
• Last updated: 2021-05-05

Locations

4 sites across 1 country: United States