NCT04032535

Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6523 After Single or Multiple Ascending Doses in Healthy Subjects, Followed by a Placebo Controlled Repeated Dose 2-way Crossover in COPD Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF6523 DPI in healthy male subjects first and then in COPD subjects after single or repeated dosesof CHF6523. As an exploratory assessment, the anti-inflammatory effect of CHF6523 in COPDsubjects will be evaluated.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	CHF6523	CHF6523 is a PI3K inhibitor (phosphoinositide3-kinase)

Timeline

• Start date: 2019-07-24
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2019-07-25
• Last updated: 2025-02-13

Locations

1 site across 1 country: United Kingdom