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Safety and PK of AIR-DNase in Healthy Adults
NCT02605590Phase 1Completed
- Sponsor
- Protalix BioTherapeutics
- Start
- Dec 2015
- Primary completion
- Feb 2016
- Modality
- Replacement Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of alidornase alfa in cystic fibrosis (CF) (4 arms), sponsored by Protalix BioTherapeutics. Primary endpoints: Adverse events following inhaled single dose (SD) of AIR-DNase at 10 days and Adverse events following inhaled multiple doses (MD) of AIR-DNase at 14 days. Started Dec 2015; status: completed.
02
Drugs
alidornase alfa
03
Conditions
cystic fibrosis (CF)
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