Phase 1 Cystic Fibrosis 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 who have been fully informed about the trial and have given their written agreement to participate.
• Healthy adults between 18 and 55 years of age (men and women).
• People whose body weight is at least 50 kg (for men) or at least 45 kg (for women), and whose Body Mass Index (BMI) falls between 19 and 28.
• People who are able to have children must agree to use highly effective birth control methods from the start of the trial until 6 months after the last dose (for women) or 3 months after the last dose (for men). Women who are able to have children must also have a negative pregnancy blood test before joining and must not be breastfeeding.

Who may not be able to join:

• People who smoked more than 5 cigarettes a day (or an equivalent amount of nicotine products) in the 3 months before screening, or who plan to use tobacco products during the trial.
• People who regularly drink alcohol above certain daily limits (more than about 3 standard drinks per day for men, or about 2 for women, on more than 2 days per week) in the 6 months before screening, who are unable to avoid alcohol during the trial, or who test positive on a breath alcohol test at the start of the trial.
• People with a history of, or current, drug misuse or dependence, or who test positive on a urine drug screen.
• People who have donated blood or lost 200 mL or more of blood in the past month, lost 400 mL or more in the past 3 months, or received a blood transfusion in the past 8 weeks.
• People who have difficulty swallowing, a fear of needles or blood, poor veins, or an inability to tolerate having blood drawn.
• People with any significant abnormal results found during physical checks, vital sign measurements, blood or urine tests, chest imaging, abdominal ultrasound, or heart (ECG) tests, as assessed by the study doctor.
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV.
• People with a known or suspected allergy to the study drug or any of its ingredients, or who have had a severe allergic reaction in the past (for example, to medicines, foods, or toxins).
• People with any active autoimmune disease or immune system deficiency at the time of screening.
• People with a history of serious illness, or any health condition that the study doctor believes could affect the trial results, affect how the drug moves through the body, or put the person at risk — including significant problems with the heart and circulation, hormones, nervous system, digestion, kidneys or urinary system, blood, immune system, mental health, or metabolism.
• People who have had surgery within the 3 months before screening, have not fully recovered as determined by the study doctor, or plan to have surgery during the trial or within 1 month after it ends.
• People considered unsuitable for the trial by the study doctors for any other reason.

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