drugset / Trial / NCT02605590
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AIR DNase | Unknown | 1.25 mg | Inhaled |
| Subject | AIR DNase | Unknown | 2.5 mg | Inhaled |
| Subject | AIR DNase | Unknown | 5 mg | Inhaled |