Phase 1 Crohn's Disease and Colitis 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 are able to communicate clearly with the research team, are willing to follow the trial requirements, and are able to sign a consent form agreeing to take part.
• Healthy adults between 18 and 55 years old (inclusive), of any gender.
• People who weigh at least 50 kg (for males) or at least 45 kg (for females), and whose body mass index (BMI) falls between 18 and 26 kg/m².
• People whose physical check-up, vital signs, heart trace (ECG), and blood and urine test results at screening are normal, or if slightly outside normal ranges, are not considered medically significant by the trial doctor.
• Women who could become pregnant must have a negative pregnancy test at the start of the trial, must not be pregnant or breastfeeding, must not be planning a pregnancy during the trial, and must agree to use acceptable contraception during the treatment period and for at least 90 days after the last dose.
• Male participants whose partners could become pregnant must agree to use acceptable contraception, use condoms, and not donate sperm during the treatment period and for at least 90 days after the last dose.

Who may not be able to join:

• People with a known or ongoing mental health condition that requires medication — such as schizophrenia, bipolar disorder, or major depression — if the trial doctor determines this could interfere with participation.
• People with any clinically significant health condition affecting organs or body systems — including the liver, kidneys, heart, lungs, digestive system, hormones, or nervous system — that the trial doctor considers unsuitable for participation.
• People with a current or suspected active infection of any kind (viral, bacterial, fungal, or parasitic).
• People with a history of frequent or long-lasting infections.
• People who have had an acute illness in the 2 weeks before screening, a significant infection (such as a respiratory infection or urinary tract infection) in the 3 months before screening, any sign of infection in the 7 days before screening, or a history of herpes simplex infection or more than one episode of shingles (herpes zoster).
• People with a history of meningococcal meningitis infection.
• People who have had their spleen removed or whose spleen does not function properly.
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People with a history of active tuberculosis, or who show signs of current or latent tuberculosis at screening.
• People with a history of allergic conditions such as asthma, eczema, chronic hives, or hay fever; people with allergies to two or more medications, foods, or pollens; or people who have had a significant allergic reaction to the study drug or similar drugs.
• People who have taken part in another clinical trial and received an investigational treatment within 30 days before the first dose (or within 5 half-lives of that study drug, whichever is longer).
• People with a history of drug misuse in the 12 months before screening, or who test positive on a urine drug screen.
• People who have taken certain medications known to strongly affect how the liver processes drugs (strong CYP3A inducers or inhibitors) within 14 days or 5 half-lives before dosing, whichever is longer (confirm with trial site).
• People who have taken prescription medications in the 14 days before dosing, or any non-prescription medications, herbal products, or supplements in the 7 days before dosing, unless the trial doctor considers these not clinically significant.
• People who have eaten foods or drinks that can affect how the liver processes drugs — such as grapefruit, Seville orange, or star fruit — in the 7 days before dosing, or who are unable to avoid caffeine in the 48 hours before dosing and throughout the inpatient period.
• People who have drunk more than 14 units of alcohol per week in the month before screening, consumed alcohol in the 24 hours before dosing, or who test positive on an alcohol screening test.
• People who have smoked more than 5 cigarettes per day in the 3 months before dosing, and who are unable to limit tobacco or nicotine use (including patches) to no more than 5 products per week from screening through to the end of the study.
• People who have donated blood or lost 200 mL or more of blood in the month before screening or dosing, or 400 mL or more in the 3 months before dosing, or who have poor vein access or difficulty tolerating blood draws.
• People whose heart trace (ECG) at screening shows clinically significant abnormalities — including a QTcF interval greater than 450 ms or other irregular heart rhythms — as determined by the trial doctor.
• People who have difficulty swallowing or who have dietary needs that prevent them from following a standardised meal plan (such as severe food allergies).
• People who have had major surgery in the 3 months before screening, or who are planning surgery during the trial.
• People who have received a vaccine in the 8 weeks before screening, or who plan to receive a vaccine during the study or within 8 weeks after the last dose.
• Anyone else who the trial doctor considers unsuitable for participation for any other reason.

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