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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2016 |
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Main ID: |
NCT02605590 |
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Date of registration:
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10/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02605590 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Israel
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Contacts
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Name:
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Einat Almon, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Protalix Ltd. |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis (CF)
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Intervention(s)
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Drug: AIR DNase
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Drug: Placebo
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Primary Outcome(s)
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Adverse events following inhaled multiple doses (MD) of AIR-DNase
[Time Frame: 14 days]
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Adverse events following inhaled single dose (SD) of AIR-DNase
[Time Frame: 10 days]
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Secondary Outcome(s)
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Area under the curve
[Time Frame: 4 hours]
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Secondary ID(s)
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PB-110-CF01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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