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:

• People who are generally healthy men or women between 18 and 60 years old (inclusive)
• Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (BMI) between 18 and 32
• People who are able to fully understand what the study involves and are willing to sign a consent form agreeing to take part
• People who agree not to try to conceive a child, donate sperm, or donate eggs from the time they sign the consent form until 3 months after their last dose, and who agree to use effective non-hormonal contraception with partners who could become pregnant during that time

Who may not be able to join:

• People who have notable abnormalities found during screening in their vital signs, physical examination, blood tests, or heart tracing (ECG), as determined by the study doctor
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who have, or have had, a clinically significant disease affecting the heart and blood vessels, hormones, metabolism, kidneys and urinary system, digestion, skin, blood, nervous system, or mental health, where the study doctor considers it unsafe to participate
• People with a history of childhood asthma (even if it resolved), depression, migraines, or a liver condition called Gilbert's Syndrome (note: people who have had their gallbladder removed are still considered eligible by the trial criteria)
• People who have had a significant infection — including a chest or throat infection — requiring antibiotic or antiviral treatment within the 14 days before or during screening
• People who have had major surgery within 4 weeks before screening, or who have planned surgery during the study
• People whose liver enzyme levels (ALP, AST, or ALT) are more than 1.5 times the upper limit of normal at screening (repeat testing may be allowed with the study doctor's approval)
• People whose kidney filtration rate is below a certain level, based on a standard calculation (repeat testing may be allowed)
• People with a known history of allergic reactions or sensitivity to any ingredient in the study medication
• People who have taken part in another clinical trial and received the study drug within 30 days or 5 half-lives (whichever is longer) before screening
• People who have received any approved or experimental biological medicine within 4 months or 5 half-lives (whichever is longer) before screening
• People who have taken prescription medicines (other than contraception), non-prescription medicines (other than paracetamol), herbal products, or dietary supplements (other than vitamins) within 2 weeks or 5 half-lives (whichever is longer) before screening
• People who have received or will receive medicines that suppress the immune system or target cancer cells, either by whole-body treatment within 6 months before screening, or by skin/topical treatment within 30 days or 5 half-lives (whichever is longer) before screening, or at any point during the study
• People who have received medicines that deplete certain immune cells (such as rituximab) within 6 months before screening
• People who have received a vaccine within 4 weeks before the first dose, or who plan to be vaccinated during the study
• People who have received immunoglobulins or blood products within 30 days before screening
• People who have donated blood or lost more than 400 mL of blood within 3 months before screening
• People who are unable to tolerate blood draws, have a history of difficult blood collection, have fainted during blood draws before, or have poor vein access
• People who have smoked more than 5 cigarettes per day (or an equivalent amount of other nicotine products) within 6 months before screening, or who are unable to avoid tobacco use during the study
• People who drink more than 14 units of alcohol per week (where 1 unit equals approximately 285 mL of beer, 25 mL of spirits, or 100 mL of wine) in the 3 months before screening; or who are unable to avoid alcohol for at least 24 hours before each clinic visit and throughout each clinic stay; or who return a positive breath alcohol test at screening (repeat testing may be allowed)
• People with a history of drug misuse, or who return a positive urine drug test at screening or the day before dosing (repeat testing may be allowed)
• People who are unable to avoid coffee, tea, chocolate, animal liver, grapefruit, pomelo, or star fruit from 3 days before dosing through the stay-in period; or who are unable to avoid intense physical exercise from 48 hours before dosing through the stay-in period; or who have other habits that could significantly affect how the body processes the study drug
• Women who are pregnant or breastfeeding
• Women who could become pregnant and return a positive pregnancy test at screening or the day before dosing
• People with any other condition that the study doctor believes would put them at risk, interfere with the study, or prevent them from completing the study

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