Trials / Unknown
UnknownNCT02722122
Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Protalix · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.
Detailed description
This is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg AIR DNase TM administered once daily for 28 days via inhalation to Cystic Fibrosis subjects who have previously been treated with Pulmozyme®. This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AIR DNase™ |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-02-01
- First posted
- 2016-03-29
- Last updated
- 2016-09-28
Locations
5 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02722122. Inclusion in this directory is not an endorsement.