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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06166056•Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Signed and dated informed consent obtained prior to any study-related procedure;
•2. Healthy male or female subject ≥18 and ≤60 years of age at screening;
•3. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
•4. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
•5. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening;
•6. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
•7. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C;
•8. Triplicate 12-lead electrocardiogram (ECG) considered as normal (40 ≤ heart rate ≤110 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤120 ms, Fridericia corrected QT interval \[QTcF\] ≤450 ms for males and QTcF ≤470 ms for females) at screening and prior to randomisation;
•9. Lung function measurements within limits at screening and prior to randomisation: forced expiratory volume in 1 second (FEV1) \>80% predicted and FEV1/forced vital capacity (FVC) ratio \>0.70;
•10. Male subjects willing to use a male condom throughout the study if they have women of childbearing potential (WOCBP) partners; male subjects with non-WOCBP partners or who are sterile do not have contraception requirements;
+13 more criteria

Exclusion Criteria

•1. Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
•2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of this protocol, according to the investigator's judgment;
•3. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the results of the study, according to the investigator's judgment;
•4. History of respiratory diseases;
•5. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology results at screening;
•6. Hepatitis serology results which indicate acute or chronic hepatitis B (HB) or hepatitis C virus (HCV) at screening;
•7. Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening or prior to randomisation, or associated complications/symptoms, which have not resolved within 2 weeks prior to screening;
•8. Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior to screening or prior to randomisation;
•9. Abnormal liver enzymes at screening or prior to randomisation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] or bilirubin: \>1.5× upper limit of normal \[ULN\]);
•10. Positive urine test for cotinine at screening or prior to randomisation;
+35 more criteria

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

Key Dates

Start Date

November 29, 2023

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Bronchiectasis

Interventions

CHF6333

DRUG

CHF6333 Placebo

DRUG

Contacts

Chiesi Clinical Trial info

CONTACT

+39 0521 2791 Clinicaltrials_info@chiesi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

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