NCT05792163

Who might be able to join this trial:

• You must be 18 years of age or older at the time you sign the consent form.
• You must be considered generally healthy by the study doctor, based on a physical check-up, medical history, vital signs, heart tracing (ECG), and blood/lab tests.
• If you are male, your weight must be between 50 and 120 kg; if you are female, between 40 and 120 kg; and your Body Mass Index (BMI) must be between 19 and 30 at the time of screening.
• If you are a woman who could become pregnant and are sexually active with a man, you must either be surgically unable to have children (e.g., hysterectomy or tubes removed), have gone through menopause for at least 1 year, or use a highly effective form of birth control from screening until at least 90 days after your last dose; you must also not be breastfeeding and must agree not to donate eggs during the study and for 90 days after your last dose.
• If you are a man who is sexually active with a woman who could become pregnant, you must use a condom, have had a vasectomy, or practice abstinence from screening until at least 90 days after your last dose, and agree not to donate sperm during this time.
• You must be able to understand and sign the consent form and follow all study rules.

Who may not be able to join:

• You have a known allergy, sensitivity, or intolerance to the study drug or any of its ingredients.
• You have any illness, condition, or ongoing treatment that the study doctor believes could interfere with the study or put you at risk.
• You have a history of difficulty swallowing or any digestive/gut condition (including Gilbert's syndrome) that affects swallowing or how your body absorbs medicines.
• You have tested positive for COVID-19 (SARS-CoV-2) before receiving the study drug, if a test is carried out.
• You have significantly abnormal results on blood or lab tests (confirm with trial site for specific limits).
• You have a history of immune system disorders, autoimmune conditions, or any inherited or acquired immune deficiency — though people with mild, well-controlled asthma (using only an occasional rescue inhaler) or mild eczema (using only moisturisers) may still be eligible (confirm with trial site).
• You have received a live vaccine within 28 days before the study drug is given, or are expected to need one during the study.
• You show signs of a current or past hepatitis B infection based on blood tests.
• You test positive for HIV or hepatitis C antibodies at the screening visit.
• You have donated more than 400 mL of blood in the 3 months before screening, or more than 200 mL in the 4 weeks before screening, or plan to donate blood during the study.
• You have had a fever or acute illness in the 7 days before your first dose, or show signs of an active infection.
• You have or have had cancer in the past 3 years, with some exceptions for certain skin cancers or localised prostate cancer that were fully treated without systemic therapy and are considered cured (confirm with trial site).
• You have a history of drug misuse, or test positive for drugs at screening or the day before dosing.
• You have a history of alcohol misuse, or test positive for alcohol at screening or the day before dosing.
• You have taken prescription medicines or herbal remedies within 14 days (or longer, depending on the medicine) before the study drug is given, or over-the-counter medicines within 7 days — with some exceptions for standard doses of paracetamol, ibuprofen, vitamins, or approved medicines (confirm with trial site); hormone replacement therapy or contraceptives that have been used consistently for at least 2 months before screening may be allowed if unchanged.
• You have eaten or drunk anything known to affect liver enzymes — such as grapefruit, citrus fruits, or their juices — within 7 days before taking the study drug.
• You have had major surgery within 6 months before screening, or plan to have surgery during the study.
• You have any other condition that the study doctor believes could affect your safety, your ability to follow the study rules, or the reliability of the results.
• You have