Trials / Completed
CompletedNCT02001688
Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"
Phase II, Double-Blind, Placebo-Controlled Study to Explore the ELF and Plasma Concentration as Well as Safety of Inhaled Alpha-1 Antitrypsin in Alpha-1 Antitrypsin Deficiency Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Kamada, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Kamada-AAT for Inhalation, 80mg | |
| DRUG | Placebo | |
| DRUG | Kamada-AAT for Inhalation, 160mg |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-02-01
- Completion
- 2016-05-01
- First posted
- 2013-12-05
- Last updated
- 2020-01-18
- Results posted
- 2020-01-18
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02001688. Inclusion in this directory is not an endorsement.