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:

• Adults aged between 18 and 55 years old.
• People with a body mass index (a measure of body weight relative to height) between 18.0 and 32.0, and who weigh at least 50 kg (if male) or at least 45 kg (if female).
• People who are able to follow all study procedures and rules, and who are willing to sign a written consent form to take part.
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant, or who agree to use a highly effective form of contraception plus condoms consistently from 30 days before the study starts until the end of the study, and who agree not to donate eggs during this period.
• Men who agree to use condoms if sexually active with a woman who could become pregnant, from the start of the study until the end, and whose female partner also agrees to use a highly effective form of contraception during this time; men who have had a surgical sterilisation procedure at least 6 months before screening may also be considered, provided they agree not to donate sperm from the study start until the end.
• People with no significant health concerns identified through their medical history, physical check-up, blood pressure and heart rate measurements, heart tracing (ECG), and blood or urine tests done within 28 days before the study treatment begins.

Who may not be able to join:

• People with a history or current diagnosis of any significant disease affecting major organs or body systems that could interfere with the study or pose a safety risk.
• People with a history of immune system problems, such as conditions that cause the immune system to be weakened or suppressed.
• People with any condition or past illness that, in the opinion of the study doctor, could affect how the body processes the study treatment.
• People whose blood test results fall outside the normal reference range in a way the study doctor considers significant, including: kidney function below a certain level; liver enzyme levels (ALT or AST) more than 1.5 times the upper limit of normal; certain elevated bilirubin levels (a substance measured in blood); or a low white blood cell count (confirm with trial site for specific thresholds).
• People whose blood pressure or heart rate falls outside the acceptable ranges set for this study (systolic blood pressure 90–140, diastolic 50–90, heart rate 40–100 beats per minute).
• People whose heart tracing (ECG) shows an abnormality the study doctor considers significant, or whose QTcF interval (a specific heart rhythm measurement) exceeds 450 milliseconds for men or 470 milliseconds for women.
• People who have had major surgery or a serious physical injury within 3 months before the study starts, or who have not fully recovered from a previous surgery or its complications.
• People with a current or past cancer diagnosis, except for certain treated skin cancers where treatment has been fully completed and follow-up is finished.
• People with a current or past active tuberculosis (TB) infection, or a latent (inactive) TB infection shown by a positive test result.
• People who test positive for HIV, hepatitis B, or hepatitis C at the screening visit.
• People who have had an infection requiring antibiotic or antiviral treatment in the 14 days before the study starts; or a serious infection requiring hospitalisation or intravenous antibiotics within 2 months before the study starts; or a history of recurring or chronic serious infections.
• People with a history of a significant allergic reaction to any medication, as determined by the study doctor.
• People who have used prescription medications within 14 days before the study starts (or within 5 half-lives of the medication, whichever is longer), or over-the-counter medications or supplements within 7 days before the study starts (except for contraception, paracetamol, and standard multivitamins).
• People who have smoked more than 5 cigarettes per day (or an equivalent amount of other nicotine products) in the 3 months before the study starts, or who are unwilling to avoid nicotine during the periods when they must stay at the study site.
• People who drink more than 14 units of alcohol per week on average (for women) or more than 21 units per week (for men) in the 6 months before the study starts, or who return a positive breath alcohol test at screening or the day before the study begins.
• People with a history of alcohol or drug dependency or addiction in the two years before screening, or who test positive for drugs at screening or the day before the study begins.
• People who have received a live vaccine within 2 months before the study starts, or who are unwilling to avoid live vaccines for at least 3 months after their last dose of the study drug.
• People who have received an inactivated vaccine (such as a COVID-19 or flu vaccine) within 14 days before the study treatment, or who plan to receive one within 14 days after.
• Women who are pregnant or currently breastfeeding.
• People who are not able to commit to taking part in all parts of the trial.
• People for whom the study doctor believes participation could pose additional risks or prevent proper evaluation of results.
• People who have previously been exposed to anti-TL1A therapy (a specific type of treatment being investigated in this area).
• People who have previously been exposed to anti-IL23 therapy (another specific type of treatment).
• People who have donated blood or plasma, or lost more than 400 mL of blood, within 30 days before screening, or who plan to donate blood at any point during the study period.
• People who have taken part in another clinical trial or used an experimental treatment within 30 days before screening, or within 5 half-lives of that treatment, whichever is longer.

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