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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02605590
Other study ID # PB-110-CF01
Secondary ID
Status Completed
Phase Phase 1
First received November 10, 2015
Last updated May 16, 2016
Start date December 2015
Est. completion date February 2016

Study information

Verified date April 2016
Source Protalix
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study will be performed to assess the safety, tolerability and PK of escalating inhaled AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive days in healthy subjects.

A thorough review of safety data will be conducted after completion of each dose level per subject and prior to both, moving to the next dose level in Part 1 and commencement of the multiple dose Part 2.


Description:

This is a Phase I study to evaluate the safety, tolerability and pharmacokinetics of inhaled AIR DNase in healthy volunteers. Up to 18 healthy males subjects (age 18 -55 inclusive) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving AIR DNase doses equivalent to 1.25 mg, 2.5mg or 5 mg or placebo in accordance. Subjects randomized to one of the cohorts will receive either active of placebo as single dose, in continuation, following safety assessments, will receive multiple doses, once daily for 5 consecutive days. Subjects will remain at the clinical center for 8 hours after the single administration of AIR DNase/placebo including PK sampling. During the multiple dosing subjects will arrive at the clinical center daily for AIR DNase/placebo administrations and study procedures and remain at the site for 4 hours post dosing.

Follow up visits will be performed 7±2 days following single administration and 7±2 days following the last administration of the multiple phase.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. Subject who understands the study procedures and provides written informed consent to participate in the study.

2. Healthy, male, 18-55 years of age, inclusive

3. Non smoker, by declaration, for at least 6 months prior to screening

4. Body mass index (BMI) = 18.5 and = 29.0 kg/m2 at screening.

5. Healthy individual with no clinically significant findings in: medical history, physical examination, laboratory profiles , vital signs, 12-lead ECG

6. Spirometry results within normal ranges.

7. A subject, whose female co-partner is of child-bearing potential, must agree to use two medically acceptable methods of contraception throughout the study.

Exclusion Criteria:

1. History of asthma, any chronic pulmonary disease, recurrent pneumonia, allergic rhinitis.

2. History of any illness or medical condition (including psychiatric) that might confound the results of the study or poses an additional risk to the subject by his participation in the study.

3. Any acute illness (e.g. acute infection) within 48 hours prior to the study drug administration, which is considered of significance by the Investigator.

4. Known contraindication, hypersensitivity and/or allergy to any drug.

5. History of adverse reactions during aerosol delivery of any medicinal product.

6. History or presence of alcoholism or drug abuse within the past 2 years prior to screening.

7. Positive urine drug of abuse test result prior to first dosing.

8. Positive breath alcohol test on admission to the CRC prior to first dosing.

9. Positive results at screening for HIV, HBsAg, or HCV Ab.

10. Sitting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.

11. Sitting heart rate is lower than 45 beats per minute (bpm) or higher than 99 bpm at screening.

12. Use of any prescription or over-the-counter medications, including vitamins, herbal, or dietary supplements within 14 days prior to dosing. Paracetamol, up to 2g /day is allowed up to 24 hours prior to dosing.

13. Donation of blood within 90 days prior to dosing.

14. Donation of bone marrow within the last 6 months prior to dosing.

15. Participation in another clinical trial within 90 days prior to dosing in which a study drug has been administered.

16. Subject is mentally or legally incapacitated or has significant emotional problems or is unable to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AIR DNase

Placebo


Locations

Country Name City State
Israel Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Protalix

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events following inhaled single dose (SD) of AIR-DNase Adverse events from subject reporting or other assessments 10 days Yes
Primary Adverse events following inhaled multiple doses (MD) of AIR-DNase Adverse events from subject reporting or other assessments 14 days Yes
Secondary Area under the curve AIR DNase concentrations measured at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, and 4 hours 4 hours No
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