NCT02815488

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6297 After Single and Repeated Ascending Doses in Healthy Male Subjects Followed by a Repeated Dose in COPD Patients and a 2-way, Crossover, Double-blind, Placebo-controlled, Repeated Dose Part to Investigate the Anti-inflammatory Effect of CHF 6297 After Lipopolysaccaride (LPS) Challenge in Healthy Male Subjects

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD patients. This study is the first administration in humans. The study will comprise four parts: Part 1 will consist of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297. Part 2 will consist of four cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297. Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297 Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect of a repeat dose of CHF6297 after LPS challenge.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	CHF6297 (Part 1 - SAD)	Single doses of CHF6297 at each period (for up to 3 periods per subject)
DRUG	Placebo (Part 1 - SAD)	Single doses of placebo matching CHF6297 at each period (for up to 3 periods per subject)
DRUG	CHF6297 (Part 2 - MAD)	Twice daily doses of CHF6297 for 7 days
DRUG	Placebo (Part 2 - MAD)	Twice daily doses of placebo matching CHF6297 for 7 days
DRUG	CHF6297 (Part 3)	Twice daily doses of CHF6297 for 14 days
DRUG	Placebo (Part 3)	Twice daily doses of placebo matching CHF6297 for 14 days
DRUG	CHF6297 (Part 4)	Twice daily doses of CHF6297 for 7 days
DRUG	Placebo (Part 4)	Twice daily doses of placebo matching CHF6297 for 7 days

Timeline

• Start date: 2016-01-22
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-06-28
• Last updated: 2020-04-17

Locations

2 sites across 1 country: United Kingdom