Phase 1 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For Parts A and B (healthy volunteers):

• People who have signed and received a copy of the approved consent form
• People aged 18 to 55 years old
• People with a body weight in proportion to their height, with a BMI between 18 and 32
• People with healthy lung function, measured at more than 90% of the expected normal value for their age and size
• People whose physical check-up, blood pressure, heart tracing (ECG), and blood test results are normal or acceptable at the screening visit
• Women who are unable to become pregnant, or people of childbearing potential who agree to use highly effective contraception during the trial

For Part C (people with cystic fibrosis):

• People aged 16 years or older
• People with a confirmed diagnosis of cystic fibrosis, including a sweat chloride test result above 60 mM
• People who have either been taking an approved cystic fibrosis medication (called a CFTR modulator) for at least 28 days before screening, or who are not taking any such medication
• People whose lung function falls within a specific range — between 40% and 90% of expected (for those on CFTR modulators), or between 40% and 100% (for those not on CFTR modulators)
• People whose cystic fibrosis condition and treatment have been stable
• Women who are unable to become pregnant, or people of childbearing potential who agree to use highly effective contraception during the trial

Who may not be able to join:

For Parts A and B:

• People with a history of any significant lung condition
• People with a history of any other significant illness or medical condition
• People with any history of cancer of any kind
• People who have had an active COVID-19 infection in the past 4 weeks
• People who test positive for HIV, hepatitis B, hepatitis C, or tuberculosis at screening
• People who have had a lower respiratory tract infection (such as bronchitis or pneumonia) in the past 6 weeks
• People who have had any active bacterial, viral, fungal, or parasitic infection in the past 4 weeks
• People who currently smoke or have smoked in the past
• People with a history of alcohol or drug misuse in the past year
• People who test positive for drugs (including cannabis), nicotine, or alcohol at screening, or who have consumed alcohol within 24 hours before a specific study visit
• People who have taken part in another clinical trial or received an experimental treatment within the past 28 days (or within 5 half-lives of the drug, whichever is longer)
• Women who are pregnant or breastfeeding
• People who have had an episode of sudden, unexpected airway tightening (paradoxical bronchospasm) in the past 12 months
• People with a pacemaker, an irregular heart rhythm, a heart electrical reading (QTc interval) above certain limits, or specific heart conduction problems (left bundle branch block or bifascicular block)
• People with a heart rate below 40 or above 100 beats per minute, or blood pressure above certain limits at screening
• People with Type 1 or Type 2 diabetes requiring medication
• People who have received any vaccine in the 30 days before the first study dose
• People who have received certain immune-suppressing medicines (such as imatinib, azathioprine, cyclosporine A, methotrexate, or others listed) within 6 months before screening
• People who have received any antibody-based or biological therapy in the 6 months before screening
• People who have received steroid treatment by mouth, injection into a vein, or into a muscle within 4 weeks before screening (injections into joints or the spine are permitted)
• People who have not received a COVID-19 vaccine in line with local guidelines, within the required timeframe before the study starts (confirm with trial site)

For Part C:

• People with any other illness or condition that could affect study results or increase the risks of taking part
• People with certain abnormal blood test results, including those related to blood cell levels, liver function, or kidney function
• People who have had a respiratory infection, a CF flare-up, or a change in their sinus or lung treatment within 28 days before screening
• People who have had any acute illness unrelated to CF within 14 days before the first study dose
• People who have had an active COVID-19 infection within 4 weeks before screening
• People who have taken part in another clinical trial or received an experimental treatment within 28 days or 5 half-lives (whichever is longer) before screening
• Women who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.