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:

• You are willing to give your consent to take part, understand what the trial involves, and agree to follow all trial procedures.
• You are between 18 and 45 years old.
• If male, you weigh at least 50 kg; if female, you weigh at least 45 kg; and your BMI is between 19 and 28 kg/m².
• You agree not to try to have children during the trial and for 28 days after the last dose, and are willing to use non-pill/non-drug forms of contraception, and will not donate sperm or eggs during this time.

Who may not be able to join:

• You have a known allergy to the study drugs (HRS-9813 capsules, nintedanib, or pirfenidone) or any of their ingredients, or you have a history of allergic conditions such as asthma, hay fever, or eczema.
• You have any health condition that might affect how your body absorbs, processes, or removes the study drug (confirm with trial site).
• You have taken part in another clinical trial or used an investigational drug or medical device within the past 3 months, or the drug from a previous trial may still be active in your body during this study.
• Your blood pressure was found to be low during screening — specifically, the top number below 90 or the bottom number below 60 mmHg.
• You tested positive for hepatitis B, hepatitis C, HIV, or syphilis during the screening period.
• You are pregnant, breastfeeding, or had a positive pregnancy test during screening or at the start of the trial.
• You donated blood, lost a large amount of blood (400 mL or more), or received a blood transfusion within the past 8 weeks (or 4 weeks for transfusions), or you plan to donate blood during the trial.
• You received a vaccine within the two weeks before screening or the start of the trial, or you plan to be vaccinated during the trial.
• You have special dietary needs that would prevent you from following the standard meals provided during the trial.
• You have difficulty swallowing, difficulty with blood draws, or a physical condition that makes frequent blood sampling a problem.
• You had a serious infection, serious injury, or major surgery within the 3 months before screening, or you plan to have surgery during the trial.
• Your heart's electrical activity (ECG) showed a clinically significant abnormality during screening — specifically, a QTcB reading above 450ms for men or above 460ms for women.
• You smoked more than 5 cigarettes a day on average in the 3 months before screening, smoked at all in the 4 weeks before screening, or are unwilling to avoid all tobacco products during the trial.
• You have a history of drug misuse or dependence, or your urine drug test came back positive at the start of the trial.
• You regularly drank more than 8 cups (250 mL each) of tea, coffee, or other caffeinated drinks per day on average in the 6 months before screening.

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