NCT04010799

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis

A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis Bronchiectasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CHF 6333 is a medicinal product on development for the treatment of cystic fibrosis and non-CF bronchiectasis and undergoing clinical testing. It has not yet been approved by the authorities for the treatment of these diseases. CHF6333 is an inhaled anti-inflammatory which mechanism of action is based on the inhibition of Human Neutrofil Elastase. The safety and tolerability of single and repeated ascending doses of inhaled CHF 6333 was previously investigated in healthy subjects: information was gathered on the uptake, distribution and excretion of the medicinal product being tested (pharmacokinetics). In this current clinical trial CHF 6333 will be tested in patients(CF and NCFB) for the first time. Three dose level will be tested during the first part of the study, as single administration. One repeated dose will be administered in the second part of the study.

Conditions

• Cystic Fibrosis
• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	CHF 6333	CHF 6333 - Part I - SAD CHF 6333 - Part II - MD
DRUG	Placebo	Placebo - Part I - SAD Placebo Part II - MAD

Timeline

• Start date: 2019-05-27
• Primary completion: 2021-03-08
• Completion: 2021-03-08
• First posted: 2019-07-08
• Last updated: 2021-03-30

Locations

1 site across 1 country: Germany