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ClinicalTrials.gov ID

NCT02722122

Lead Sponsor

ProtalixINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

15Estimated

Last Update Posted

Sep 28, 2016Estimated

Start Date

May 2016

Primary Completion Date

Feb 2017Estimated

Official Title

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®

Brief 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.

• Cystic Fibrosis

• AIR DNase™

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Main Inclusion Criteria:

1. Age ≥ 12 years of age (inclusive) at the time of screening
2. Weight ≥ 36 kg
3. Prior confirmed diagnosis of CF
4. At least 4 months treatment with Pulmozyme® prior to screening.
5. The subject is medically stable for at least one month prior to the screening visit.
6. Stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least four months prior to screening visit.
7. FEV1 of >40% and <90% and FVC ≥ 40% of predicted normal for age, gender, and height at screening .
8. Female and male subjects whose co-partners are of child bearing potential must agree to use two medically acceptable methods of contraception, not including the rhythm method.
9. Be willing and able to adhere to the study visit schedule and other protocol requirements
10. Be willing and able to provide voluntary written informed consent

Main Exclusion Criteria:

1. Has a history of lung transplantation.
2. Female subjects who are pregnant or lactating.
3. History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
4. History or presence of hypersensitivity or reaction to inhaled proteins.
5. Participation in another clinical trial within 60 days prior to screening.
6. Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's safety or compliance with the requirements of the study.
7. Have positive serology for human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infection.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

ProtalixINDUSTRY

04-7774360

02-6777749

03-5302884