Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the 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 18 or older who are willing to volunteer and sign a consent form.
• People diagnosed with pulmonary fibrosis (scarring of the lungs) of known or unknown cause — except for the specific type called IPF — who have already received standard treatment or monitoring for at least 3 months.
• People whose lung fibrosis has been getting worse in the 12 months before screening, shown by at least two of the following: worsening symptoms like cough or breathlessness; lung function tests showing a meaningful decline in breathing capacity; or chest scans showing signs of disease progression — where no other cause (such as infection or heart failure) explains these changes.
• People whose high-resolution CT scan shows fibrosing lung disease affecting more than 10% of the lungs, as confirmed by specialist reviewers.
• People with an underlying autoimmune (connective tissue) disease, provided that disease has been stable — meaning no new treatments started, no dose changes, and no treatments stopped — in the 12 weeks before joining the trial.
• People whose lung function test results fall within specific ranges: a breathing ratio (FEV1/FVC) of 0.7 or above before using an inhaler; a breathing capacity (FVC) of at least 45% of the expected normal value; and a measure of how well the lungs transfer oxygen into the blood (DLCO) between 30% and 80% of the expected normal value.
• People who are able and willing to follow the study schedule and attend all required visits, as assessed by the trial doctor.
• People of childbearing potential (male or female) who agree to use effective contraception from signing the consent form until 30 days after the last dose of study medication.

Who may not be able to join:

• People diagnosed with Idiopathic Pulmonary Fibrosis (IPF), which is a specific type of lung scarring disease.
• People with other significant lung abnormalities that the trial doctor believes could affect study results.
• People with serious high blood pressure in the lungs (pulmonary arterial hypertension), including those with evidence of significant right-sided heart failure, certain results from heart catheterisation tests, or those who require specific intravenous medications for this condition.
• People with major physical problems outside the lungs that affect breathing, such as chest wall deformities or large fluid collections around the lungs.
• People who are expected to need a lung transplant during the study period.
• People whose expected survival is less than 6 months.
• People who have had a cancer diagnosis in the past 5 years, with the exception of certain localised skin cancers (basal cell carcinoma) or cervical carcinoma in situ.
• People with a thyroid condition that the trial doctor considers significant enough to require treatment.
• People who have had unstable or worsening heart problems in the 6 months before screening, including unstable chest pain (angina), a recent heart attack, significant heart failure, or serious uncontrolled abnormal heart rhythms.
• People with certain abnormal liver blood test results above specified thresholds (confirm with trial site).
• People with reduced kidney function below a specific level (confirm with trial site).
• People who test positive for HIV or syphilis.
• People with uncontrolled hepatitis B or hepatitis C infection.
• People who have recently taken certain medications that could interfere with the study drug or with lung disease treatment, including specific immune-suppressing drugs, high-dose steroids, the existing fibrosis drugs pirfenidone or nintedanib, certain biological therapies, or strong inhibitors/inducers of a liver enzyme called CYP3A4 — within specified time periods before joining (confirm exact timeframes with trial site).
• People who are unable to complete lung function tests, a 6-minute walk test, or study questionnaires.
• People with a known allergy to any ingredient in the study drug (HEC585 Tablets).
• People who have taken part in another clinical trial and received a study drug within 3 months before screening.
• People who are pregnant or breastfeeding.
• People who have smoked 10 or more cigarettes per day in the 3 months before screening, or who are unwilling to stop smoking during the study.
• People with a history of alcohol or drug misuse in the 6 months before screening.
• People who, in the trial doctor's judgement, have any other condition that could affect their safety or their ability to complete the study.

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