Phase 1 Cystic Fibrosis Trial, Completed

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 healthy volunteers:

• Men aged 18 to 50 years old in good health
• People who are able to communicate with the study team and are willing to sign a consent form
• People who are able and willing to attend all required study visits and follow the study rules
• People whose weight and height fall within a specific healthy range (body mass index between 20 and 30, and weight between 60 and 90 kg)
• People with no significant health problems found during screening checks, including blood tests, urine tests, a heart tracing (ECG), and no signs of drug or alcohol use at screening
• People whose test results are negative for HIV, Hepatitis B, and Hepatitis C
• People whose lung breathing test (measuring how much air can be breathed out in one second) is above 75% of what is expected for their age

For people with cystic fibrosis (CF):

• People who are able to communicate with the study team and are willing to sign a consent form
• People who are able and willing to attend all required study visits and follow the study rules
• People who have a confirmed CF diagnosis, established through at least two recognised methods (such as a sweat test, a nasal test, or genetic testing showing two CF-related gene changes, along with typical CF symptoms)
• People aged 18 years or older
• People whose lung breathing test result is above 40% of what is expected
• People who are able to carry out the breathing tests required by the study
• People whose liver enzyme levels are not more than twice the upper limit of the normal range
• People who are able to naturally cough up mucus from their lungs every day

Who may not be able to join:

For healthy volunteers:

• People with a history of lung conditions or other disorders that may affect how a drug is absorbed by the body
• People with signs of significant problems affecting the breathing, kidneys, liver, brain or nervous system, heart, or metabolism
• People with a history of allergic reactions to vancomycin or any ingredient in the study drug
• People who currently smoke, or ex-smokers who have not been smoke-free for at least one full year before the study drug is given
• People who have had a respiratory tract infection (such as a cold or chest infection) within two weeks before the first study drug dose
• People who have taken any prescription or over-the-counter medicines, vitamins, or mineral supplements within 48 hours before the study drug is given
• People who have received a vaccination within one month before the study drug is given
• People whose blood pressure reading falls outside a specific range at screening (confirm with trial site)
• People with a history of drug or alcohol misuse
• People who have taken part in another clinical trial within three months before the study drug is given
• People who have donated blood or plasma within three months before the study drug is given
• People with any other condition that, in the study doctor's opinion, could affect the study or pose a risk to the person

For people with cystic fibrosis (CF):

• People who have taken any other investigational (trial) drug or used an investigational device within 28 days of screening, or within six half-lives of that drug
• People taking oral corticosteroids (steroid tablets or liquid) at doses above 10 mg per day or 16 mg every other day
• People who have had a sputum or throat swab test showing a bacteria called Burkholderia cepacia in the past two years
• People with a history of a particular antibiotic-resistant bacteria (MRSA) in their sputum, or whose screening test shows MRSA
• People who need continuous oxygen every day, or more than 2 litres per minute of oxygen overnight
• People with a history of allergic reactions to vancomycin or any ingredient in the study drug
• People who have made changes to their antibiotic, airway-opening, anti-inflammatory, or steroid medicines within 7 days before screening
• People who have changed their physiotherapy routine or schedule within 7 days before screening
• People who have previously had a lung transplant
• People whose chest X-ray (taken at screening or within the 90 days before screening) shows a significant new finding such as a collapsed area of lung, air outside the lung, or fluid around the lung
• People with a positive pregnancy test — all women who could potentially be pregnant will be tested
• Women who could become pregnant and are breastfeeding, or who are not using an accepted form of contraception (such as hormonal methods, barrier methods, or an intrauterine device)
• People whose screening results raise concerns about their safety or the quality of the study data, in the study doctor's opinion
• People with a history of severe coughing or airway spasm when inhaling dry powder medicines
• People considered to be terminally ill or already assessed as eligible for a lung transplant
• People who have had a significant coughing-up-of-blood episode (more than 60 mL) in the three months before joining the study

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