Asthma Clinical Trial
Official title:
A First In Human Randomised, Double-Blind, Placebo-Controlled Study Of Single Ascending Doses In Healthy Male Volunteers And Repeated Ascending Dose In Asthmatic Patients Followed By A 3-Way Cross-Over, Placebo-Controlled, Single-Dose In Copd Patients To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CHF6366
CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and
β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal
bronchodilation after inhalation dosing via two validated mechanisms in one molecule.
The study will consist of three parts:
Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability
and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366
Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability
and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366
Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single
dose of CHF6366 in an active and placebo controlled design
n/a
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