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Tests treatment safety and results for Bronchiectasis
Official title 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
ClinicalTrials.gov ID: NCT06166056
What this study is testing
What is CHF6333?
CHF6333 is an investigational medicine, being studied as a potential treatment for bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Signed and dated informed consent obtained prior to any study-related procedure;
- Healthy male or female subject ≥18 and ≤60 years of age at screening;
- Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak...
- Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
- Non-smokers or ex-smokers who smoked \ 1 year prior to screening;
You likely can't join if
- Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior...
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or...
- Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may...
- History of respiratory diseases;
- Positive human immunodeficiency virus (HIV) 1 or HIV2 serology results at screening;
- Hepatitis serology results which indicate acute or chronic hepatitis B (HB) or hepatitis C virus (HCV) at screening;
See the full eligibility criteria
Who can join
- Signed and dated informed consent obtained prior to any study-related procedure;
- Healthy male or female subject ≥18 and ≤60 years of age at screening;
- 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...
- Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
- Non-smokers or ex-smokers who smoked \ 1 year prior to screening;
- Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
- 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;
- 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...
- 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;
- Male people willing to use a male condom throughout the study if they have women of childbearing potential (WOCBP) partners; male people with non-WOCBP partners or who are sterile do not have contraception requirements;
- Female people (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female people who are non-WOCBP or...
What rules you out
- Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of...
- 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...
- History of respiratory diseases;
- Positive human immunodeficiency virus (HIV) 1 or HIV2 serology results at screening;
- Hepatitis serology results which indicate acute or chronic hepatitis B (HB) or hepatitis C virus (HCV) at screening;
- 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;
- Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior to screening or prior to randomisation;
- 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]);
- Positive urine test for cotinine at screening or prior to randomisation;
- Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test at screening or prior to randomisation;
- Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen at screening or prior to randomisation;
- Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
- Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or prior to randomisation;
- Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
- Unsuitable veins for repeated venepuncture;
- Heavy caffeine drinker;
- For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin...
- Use of any kind of electronic smoking devices within 6 months prior to screening. Part I BE people Inclusion Criteria:
- Signed and dated informed consent obtained prior to any study-related procedure;
- Male or female subject ≥18 and ≤80 years of age at screening;
- Clinical history consistent with BE (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed by chest computed tomography (CT) demonstrating BE affecting 1 or more lobes...
- Post-bronchodilator FEV1 ≥50% of the predicted value at screening;
- If currently receiving treatment for BE, this treatment should be administered at a stable dose;
- people in a stable clinical condition with no exacerbation of BE for at least 4 weeks prior to randomisation. A pulmonary exacerbation is defined as a deterioration in three or more of the key symptoms for at least 48...
- Vital signs within normal limits at screening and prior to randomisation: DBP ≥40 and ≤89 mmHg, and SBP ≥90 and ≤150 mmHg; body temperature \<37.5°C;
- Ability to understand the study procedures and the risks involved, and the ability to be trained to use the inhalers correctly and to generate sufficient PIF (at least 40 L/min) using the In-Check Dial set as per...
- Male people willing to use a male condom throughout the study if they have WOCBP partners; male people with non-WOCBP partners or who are sterile do not have contraception requirements;
- Female people (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female people who are non-WOCBP or...
- History of a clinically meaningful unstable or uncontrolled chronic comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering the study...
- Acute symptomatic respiratory tract infection which constitutes an increase from the subject's baseline, per the investigator's judgment, within 4 weeks prior to randomisation;
- Abnormal and clinically significant 12-lead ECG at screening or prior to randomisation that results in an active medical problem, which may impact the safety of the subject, per the investigator's judgment. Male people...
- Clinically significant abnormal laboratory values at screening that, in the opinion of the investigator, may put the subject at risk by participating in the study, or interfere with the subject's treatment or...
- Participation in another clinical study, where investigational drug was received less than 30 days or less than 5 half-lives of the previous administered product (whichever is longer) prior to screening; participation...
- Primary diagnosis of asthma, as determined by the investigator;
- Concomitant diagnosis of cystic fibrosis;
- Diagnosis of chronic obstructive pulmonary disease (COPD) made by a clinician, with airflow obstruction (post-bronchodilator FEV1/FVC ratio \<0.7) and at least a 10 pack-year smoking history; people with documented COPD...
- Current smokers; ex-smokers must have stopped for at least 1 year prior to screening (≥6 months for electronic smoking devices);
- people with an active tuberculous mycobacteria (TM) or non-tuberculous mycobacteria (NTM) infection requiring or receiving antibiotic treatment, an active allergic bronchopulmonary aspergillosis requiring treatment with...
- Diagnosis of common variable immunodeficiency (CVID) or other immunodeficiencies requiring immunoglobulin treatment, based on subject history;
- Diagnosis of rheumatoid arthritis;
- Malignancy that has not been in complete remission for at least 1 year or any untreated localised carcinomas;
- History of solid organ/haematological transplantation and receiving immunosuppressive therapy;
- Use of any antimicrobials (oral, inhaled, or intravenous) within 4 weeks prior to randomisation, except for people who are on stable treatment with macrolide antibiotics (for at least 3 months);
- Medical history of discontinuation of previous inhaled therapy due to bronchospasm or intolerance;
- Documented COVID-19 diagnosis within 4 weeks prior to randomisation, or associated complications/symptoms;
- Diagnosis of alpha-1-antitrypsin (AAT) deficiency defined as an AAT serum level \<110 mg/dL; a prior test result of AAT serum level to confirm the diagnosis will be acceptable. In the event that a prior result is not...
- Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
- people treated with monoclonal antibodies (mAbs) for any respiratory conditions;
- people with traction BE;
- For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin...
- Positive HIV1 or HIV2 serology results at screening;
- Hepatitis serology results which indicate acute or chronic HB or HCV at screening;
- BMI ≤17 kg/m2 at screening. Part II BE people Inclusion Criteria: the people must meet all the inclusion criteria listed in Part I for people with BE (Cohort B), except the inclusion criterion below: 4\...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Dundee, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Dundee, United Kingdom; Edinburgh, United Kingdom; Glasgow, United Kingdom; Leeds, United Kingdom; London, United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.