RecruitingPhase 1Phase 2NCT06166056

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Ascending Doses in Healthy Volunteers and One Single Dose in Adult Subjects With Bronchiectasis, Followed by a Placebo-controlled, Repeated Dose, 3-way Cross-over in Adult Subjects With Bronchiectasis


Sponsor

Chiesi Farmaceutici S.p.A.

Enrollment

45 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to assess the safety of: * single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I * repeated doses of the study drug CHF6333 in subjects with BE - Part II


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CHF6333 and a drug called CHF6333 Placebo for people with bronchiectasis. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCHF6333

CHF6333 Part I SAD; CHF6333 Part II MD.

DRUGCHF6333 Placebo

Placebo Part I SAD; Placebo Part II MD.


Locations(9)

Royal Papworth Hospital NHS Foundation Trust, Cambridge Centre for Lung Infection

Cambridge, United Kingdom

Tayside Medical Science Centre, Ninewells Hospital & Medical School

Dundee, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Glasgow Royal Infirmary

Glasgow, United Kingdom

The Leeds Teaching Hospitals NHS Trust, Saint James's University Hospital

Leeds, United Kingdom

Royal Bromptom Hospital (NHS Guy's and Thomas')

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Medicines Evaluation Unit (MEU)

Manchester, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

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NCT06166056


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