drugset / Trial / NCT02605590

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

NCT02605590 ↗

Phase 1 Completed 18 enrolled Protalix
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-12
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject AIR DNase Unknown 1.25 mg Inhaled
Subject AIR DNase Unknown 2.5 mg Inhaled
Subject AIR DNase Unknown 5 mg Inhaled

Indications