Back to results

Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers

Primary Purpose

Cystic Fibrosis (CF)

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

AIR DNase

Placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis (CF)

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Subject who understands the study procedures and provides written informed consent to participate in the study.
Healthy, male, 18-55 years of age, inclusive
Non smoker, by declaration, for at least 6 months prior to screening
Body mass index (BMI) ≥ 18.5 and ≤ 29.0 kg/m2 at screening.
Healthy individual with no clinically significant findings in: medical history, physical examination, laboratory profiles , vital signs, 12-lead ECG
Spirometry results within normal ranges.
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:

History of asthma, any chronic pulmonary disease, recurrent pneumonia, allergic rhinitis.
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.
Any acute illness (e.g. acute infection) within 48 hours prior to the study drug administration, which is considered of significance by the Investigator.
Known contraindication, hypersensitivity and/or allergy to any drug.
History of adverse reactions during aerosol delivery of any medicinal product.
History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
Positive urine drug of abuse test result prior to first dosing.
Positive breath alcohol test on admission to the CRC prior to first dosing.
Positive results at screening for HIV, HBsAg, or HCV Ab.
Sitting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
Sitting heart rate is lower than 45 beats per minute (bpm) or higher than 99 bpm at screening.
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.
Donation of blood within 90 days prior to dosing.
Donation of bone marrow within the last 6 months prior to dosing.
Participation in another clinical trial within 90 days prior to dosing in which a study drug has been administered.
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).
-

Sites / Locations

Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

1.25 mg

2.5 mg

5 mg

Placebo

Arm Description

Part 1: single inhaled dose of 1.25 mg AIR-DNase followed by Part 2: once daily inhaled dose of 1.25 mg AIR DNase for 5 consecutive days.

Part 1: single inhaled dose of 2.5 mg AIR-DNase followed by Part 2: once daily inhaled dose of 2.5 mg AIR DNase for 5 consecutive days.

Part 1: single inhaled dose of 5 mg AIR-DNase followed by Part 2: once daily inhaled dose of 5 mg AIR DNase for 5 consecutive days.

Placebo comparator for each of the dose levels, administered accordingly as single inhaled dose in Part 1 followed by once daily inhaled dose for 5 consecutive days in Part 2.

Outcomes

Primary Outcome Measures

Adverse events following inhaled single dose (SD) of AIR-DNase

Adverse events from subject reporting or other assessments

Adverse events following inhaled multiple doses (MD) of AIR-DNase

Adverse events from subject reporting or other assessments

Secondary Outcome Measures

Area under the curve

AIR DNase concentrations measured at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, and 4 hours

Full Information

NCT ID

NCT02605590

First Posted

November 10, 2015

Last Updated

May 16, 2016

Sponsor

Protalix

1. Study Identification

Unique Protocol Identification Number

NCT02605590

Brief Title

Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Protalix

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis (CF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1.25 mg

Arm Type

Experimental

Arm Description

Part 1: single inhaled dose of 1.25 mg AIR-DNase followed by Part 2: once daily inhaled dose of 1.25 mg AIR DNase for 5 consecutive days.

Arm Title

2.5 mg

Arm Type

Experimental

Arm Description

Part 1: single inhaled dose of 2.5 mg AIR-DNase followed by Part 2: once daily inhaled dose of 2.5 mg AIR DNase for 5 consecutive days.

Arm Title

5 mg

Arm Type

Experimental

Arm Description

Part 1: single inhaled dose of 5 mg AIR-DNase followed by Part 2: once daily inhaled dose of 5 mg AIR DNase for 5 consecutive days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator for each of the dose levels, administered accordingly as single inhaled dose in Part 1 followed by once daily inhaled dose for 5 consecutive days in Part 2.

Intervention Type

Drug

Intervention Name(s)

AIR DNase

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Adverse events following inhaled single dose (SD) of AIR-DNase

Description

Adverse events from subject reporting or other assessments

Time Frame

10 days

Title

Adverse events following inhaled multiple doses (MD) of AIR-DNase

Description

Adverse events from subject reporting or other assessments

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Area under the curve

Description

AIR DNase concentrations measured at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, and 4 hours

Time Frame

4 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject who understands the study procedures and provides written informed consent to participate in the study. Healthy, male, 18-55 years of age, inclusive Non smoker, by declaration, for at least 6 months prior to screening Body mass index (BMI) ≥ 18.5 and ≤ 29.0 kg/m2 at screening. Healthy individual with no clinically significant findings in: medical history, physical examination, laboratory profiles , vital signs, 12-lead ECG Spirometry results within normal ranges. 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: History of asthma, any chronic pulmonary disease, recurrent pneumonia, allergic rhinitis. 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. Any acute illness (e.g. acute infection) within 48 hours prior to the study drug administration, which is considered of significance by the Investigator. Known contraindication, hypersensitivity and/or allergy to any drug. History of adverse reactions during aerosol delivery of any medicinal product. History or presence of alcoholism or drug abuse within the past 2 years prior to screening. Positive urine drug of abuse test result prior to first dosing. Positive breath alcohol test on admission to the CRC prior to first dosing. Positive results at screening for HIV, HBsAg, or HCV Ab. Sitting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening. Sitting heart rate is lower than 45 beats per minute (bpm) or higher than 99 bpm at screening. 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. Donation of blood within 90 days prior to dosing. Donation of bone marrow within the last 6 months prior to dosing. Participation in another clinical trial within 90 days prior to dosing in which a study drug has been administered. 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). -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Einat Almon, PhD

Organizational Affiliation

Protalix Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Sourasky Medical Center

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers

We'll reach out to this number within 24 hrs