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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 27 Jun 2021

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At a glance

  • Drugs CHF-6366 (Primary) ; Umeclidinium; Vilanterol
  • Indications Asthma; Chronic obstructive pulmonary disease
  • Focus Adverse reactions; First in man
  • Sponsors Chiesi Farmaceutici

    • Most Recent Events

    • 19 May 2021 Results (n=34) assessing safety and pharmacokinetics of CHF 6366 in healthy male volunteers, presented at the 117th International Conference of the American Thoracic Society.
    • 08 May 2019 Status changed from recruiting to completed.
    • 27 Nov 2018 Planned End Date changed from 28 Aug 2018 to 28 Jun 2019.

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