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

NCT02605590 | Completed Phase 1

• 1 other identifier: PB-110-CF01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis (CF)

Outcome Measures

Primary Outcomes (2)

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

  Adverse events from subject reporting or other assessments

  10 days

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

  Adverse events from subject reporting or other assessments

  14 days

Secondary Outcomes (1)

• Area under the curve

  4 hours

Study Arms (4)

1.25 mg

EXPERIMENTAL

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.

Drug: AIR DNase

2.5 mg

EXPERIMENTAL

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.

Drug: AIR DNase

5 mg

EXPERIMENTAL

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.

Drug: AIR DNase

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AIR DNase DRUG

1.25 mg; 2.5 mg; 5 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protalix: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Einat Almon, PhD

  Protalix Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 16, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-04

Locations

IL (1)