NCT03056326

A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Non-Cystic Fibrosis Bronchiectasis
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	CHF6333 (Part 1 - SAD)	Single doses of CHF6333 at each period
DRUG	Placebo (Part 1 - SAD)	Single doses of placebo matching CHF6333 at each period
DRUG	CHF6333 (Part 2 - MAD)	once daily multiple doses of CHF6333 for 14 days
DRUG	Placebo (Part 2 - MAD)	once daily multiple doses of placebo matching CHF6333 for 14 days

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-02-17
• Last updated: 2017-11-07

Locations

1 site across 1 country: Belgium