Phase 1 Crohn's Disease and Colitis Trial, Not Yet 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 between 18 and 65 years old (inclusive) at the time of screening
• You weigh between 50 and 110 kg (approximately 110–243 lbs) at screening
• Your Body Mass Index (BMI) — a measure of body weight relative to height — is between 18.0 and 30.0 at screening
• If you are a woman, you are either not pregnant and not breastfeeding, or you are not able to become pregnant (due to surgery, natural reasons, or having gone through menopause for at least 12 months in a row); a pregnancy test will be done to confirm you are not pregnant
• If you are a woman who could become pregnant and have a male partner, you must agree to use effective birth control starting at least 4 weeks before taking the study drug until 90 days after your final visit (this includes hormonal contraceptives or an IUD combined with a diaphragm, cervical cap, or condom; or complete abstinence from sex)
• If you are a man and have not had a surgical procedure to prevent fathering children, you must agree to use effective birth control and not donate sperm from your first visit until 90 days after your final visit (same birth control methods apply as above)
• Your blood pressure and heart rate are within a healthy range at screening (blood pressure roughly 90–140 over 45–90, heart rate 40–100 beats per minute)
• You have stopped taking all prescription medications at least 30 days before your first visit (hormonal contraceptives are the only exception)
• You have stopped taking all over-the-counter medicines, vitamins, supplements, and herbal products (such as St. John's Wort) at least 14 days before your first visit (regular paracetamol/acetaminophen is allowed up until admission)
• You are willing and able to avoid alcohol for at least 48 hours before screening and before each visit to the research centre
• You are willing and able to avoid coffee, tea, cola, chocolate, energy drinks, and grapefruit (or grapefruit juice) for at least 48 hours before each visit to the research centre
• You are in good physical and mental health, as assessed by the study doctor through medical history, physical exam, lab tests, heart tracing (ECG), and vital signs
• You are willing and able to sign the informed consent form agreeing to participate

Who may not be able to join:

• You have previously taken part in this same study
• You are an employee of ICON or the company sponsoring this trial
• You have a history of significant allergies to drugs or certain foods
• You have used tobacco products (such as cigarettes) within the past 2 months
• You have a history of alcohol abuse or addiction to drugs, including cannabis (marijuana)
• You test positive for drugs or alcohol at screening or at any visit to the research centre (this includes opioids, cocaine, cannabis, amphetamines, and others)
• You drink more than 24 units of alcohol per week on average (1 unit = roughly a small glass of wine, half a pint of beer, or a single shot of spirits)
• You test positive for hepatitis B, hepatitis C, or HIV
• You have taken part in another drug study within the past 30 days, or in 4 or more drug studies within the past 12 months
• You have donated or lost more than 450 mL of blood in the past 60 days, or more than 1.5 litres (men) / 1.0 litre (women) in the past 10 months
• You have had a significant or sudden illness within 5 days before your first dose that could affect safety results, in the opinion of the study doctor
• You are unwilling to eat the specific standardised breakfast required by the study (referred to as the "FDA breakfast")
• Your veins are not suitable for giving injections or taking blood samples
• You have a COVID-19 (SARS-CoV-2) vaccine planned between 2 weeks before your first visit and your final follow-up visit
• You have recently tested positive for COVID-19, or have had close contact with a confirmed COVID-19 case within 2 weeks before your admission

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