drugset / Trial / NCT02001688
Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 80 mg | Inhaled |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 160 mg | Inhaled |