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:

• Healthy male volunteers of Korean or Caucasian background, aged 19 to 60 years at the time of screening.
• People who weigh at least 50.0 kg and have a Body Mass Index (BMI) between 18.5 and 29.9 kg/m² at the time of screening (BMI is a measure calculated from height and weight).
• People whose blood test at screening shows a level of a protein called serum amphiregulin at 100 pg/mL or higher.
• People who have been fully informed about the trial, have understood what it involves, and have voluntarily agreed in writing to take part and follow the required guidelines.

Who may not be able to join:

• People who have, or have had, significant health conditions affecting the liver, kidneys, nervous system, immune system, lungs, digestive system, hormones, blood, heart, urinary system, mental health (such as mood disorders), or sexual function.
• People who have had a significant allergic or hypersensitivity reaction to RNA-based medicines or other drugs (such as aspirin or antibiotics), or who have conditions such as severe allergies or asthma.
• People whose blood tests at screening come back positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People who have a history of drug abuse or whose urine test at screening shows the presence of drugs of abuse.
• People whose vital signs at screening fall outside the acceptable ranges, including blood pressure, pulse rate, or body temperature outside the specified limits (confirm with trial site for exact values).
• People whose heart tracing (ECG) at screening shows abnormal heart rhythm or a QTcF measurement above 450 milliseconds.
• People whose blood test results at screening show liver enzyme levels (AST or ALT) above 60 IU/L, or kidney function (measured by a specific formula) below 60 mL/min/1.73 m².
• People who have taken prescription medicines or herbal remedies within two weeks before the first planned dose, or over-the-counter medicines, health supplements, or vitamins within one week before the first planned dose (the investigating doctor may make exceptions in some cases).
• People who have taken certain medicines that affect how the body processes drugs — such as barbiturates or clarithromycin — within one month before the first planned dose.
• People who have taken part in another clinical trial and received an investigational drug within six months before the first planned dose.
• People who have donated whole blood within two months, donated blood components within one month, or received a blood transfusion before the first planned dose.
• People who currently smoke, or who have not stopped smoking at least three months before the first planned dose, or who are unable to remain smoke-free for the duration of the trial.
• People who regularly drink more than 21 units of alcohol per week, or who are unable to avoid alcohol from three days before the first planned dose until the end of the trial.
• People who regularly consume more than five units of caffeine per day, or who are unable to avoid caffeine-containing food and drinks from three days before the first planned dose until the end of the trial.
• People who are unable to avoid grapefruit, grapefruit juice, or foods containing grapefruit from three days before the first planned dose until the end of the trial.
• People who have unusual eating habits or who are unable to follow the standardised meals provided by the trial centre during their stay.
• People whose female partner of childbearing potential does not agree to use a highly effective method of contraception from three days before the first planned dose until the end of the trial (confirm with trial site for accepted contraception methods).
• People who do not agree to avoid donating sperm from three days before the first planned dose until the end of the trial.
• People considered unsuitable for the trial by the investigating doctor for any other reason.

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