A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic
lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable
inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed
to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in
healthy male subjects.
The study will comprise two parts:
Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety,
tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.
Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety,
tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333