drugset / Trial / NCT02001688

Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"

NCT02001688

Phase 2 Completed 36 enrolled Kamada, Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate different doses of "Kamada-AAT for Inhalation" on the levels of alpha 1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to assess the safety of the treatment in subjects with AAT Deficiency.

Timeline

Start
2014-04
Primary completion
2016-02
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 80 mg Inhaled
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 160 mg Inhaled