Phase 1 Interstitial Lung Disease 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:

• People aged 40 to 85 years old at the time of signing the consent form
• People who have been diagnosed with IPF (idiopathic pulmonary fibrosis)
• People who are either not currently taking any IPF medication, or who have been taking pirfenidone or nerandomilast at a steady dose for at least 3 months before the screening visit
• People whose lung capacity (FVC) is measured at more than 45% of the expected normal level during screening
• People whose lung gas exchange ability (DLCO, adjusted for blood count) is at least 40% of the expected normal level, either from a test done within the past 12 months or during screening
• People who weigh more than 40 kg (88 lbs) at the time of screening
• Women who could become pregnant must agree to use an acceptable form of birth control during the trial
• Men who could father a child and are sexually active with women who could become pregnant must agree to use a recommended method of contraception during the trial
• People who are physically able to perform breathing tests (spirometry) according to standard guidelines
• People who have had a chest CT scan within the past 2 years showing results consistent with an IPF diagnosis, as assessed by the investigating doctor

Who may not be able to join:

• People whose lung disease has a known cause, such as radiation exposure, sarcoidosis, hypersensitivity pneumonitis, or bronchiolitis obliterans organising pneumonia
• People who have been diagnosed with a connective tissue disease, such as scleroderma, lupus, rheumatoid arthritis, or polymyositis/dermatomyositis, regardless of whether it is thought to be linked to their lung condition
• People with significant physical restrictions outside the lungs that affect breathing, such as chest wall abnormalities or large fluid build-up around the lungs (confirm with trial site)
• People with significant heart or cardiovascular disease (confirm with trial site for specific conditions)
• People who have had a significant whole-body infection in the 4 weeks before screening, or who have an active viral or bacterial infection at the time of screening
• People who have been hospitalised in the past 3 months for COVID-19, an acute worsening of IPF, or any lower respiratory tract infection
• People with a history of asthma, unless it was a childhood condition that fully resolved
• People with a known obstructive lung disease diagnosis
• People whose liver enzyme levels (ALT or AST) or total bilirubin are more than 1.5 times the upper limit of the normal range at screening
• People with advanced liver or kidney disease (confirm with trial site for specific thresholds)
• People who are currently taking or have taken nintedanib within the 30 days before screening
• People who have taken prednisone at more than 10 mg per day within the month before screening, or who are on other significant immune-suppressing medications
• People with active lung cancer or any cancer that has required chemotherapy or radiation treatment within the past 3 years — exceptions may apply for certain treated skin cancers, localised prostate conditions, or cervical in situ carcinoma (confirm with trial site)
• People who have taken part in another clinical trial of a new drug, device, or prescription medicine within 1 month before screening
• People with current problems related to alcohol, medication misuse, or illicit drug use
• People who have donated more than 400 mL of blood or blood products in the 3 months before screening
• People who have received a live vaccine within 3 months before the first dose of the study drug
• People who have smoked any substance — including cigarettes, electronic cigarettes, or marijuana — within the 3 months before screening, or who gave up cigarette smoking less than 1 year ago
• People who require more than 6 litres of oxygen per minute while at rest

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