NCT02605590

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Protalix · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	AIR DNase
DRUG	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-11-16
• Last updated: 2016-05-17

Locations

1 site across 1 country: Israel