Phase 1 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the 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 male or female, aged 18 to 55 years old, with a body mass index (a measure of body weight relative to height) between 18.5 and 32.0, who have not used any tobacco or nicotine products in the 3 months before screening
• People who are generally in good health, with no significant illnesses or surgery in the 4 weeks before the study drug is given, and no significant history of major diseases affecting the brain, heart, lungs, kidneys, liver, digestive system, immune system, or mental health
• Female participants who cannot become pregnant must either have gone through natural menopause (no periods for at least 12 months, confirmed by a hormone blood test) or have had a surgical procedure that prevents pregnancy (such as removal of the ovaries, fallopian tubes, or uterus, or tubal occlusion) at least 3 months before dosing
• Participants must be willing to avoid donating sperm for 90 days, or eggs for 6 months, after the last dose of the study drug
• Sexually active females who could become pregnant, and males who have not had a sterilisation procedure, must be willing to use an approved method of contraception throughout the study
• People who are able to understand the study procedures and are willing to sign a consent form agreeing to take part

Who may not be able to join:

• People with any significant abnormal findings during a physical examination
• People with significantly abnormal results from blood, urine, or other laboratory tests, or who test positive for hepatitis B, hepatitis C, HIV, or tuberculosis at screening
• People who are pregnant or currently breastfeeding
• People who test positive for drugs, nicotine, or alcohol at screening or the day before dosing begins
• People with a history of serious allergic reactions (such as anaphylaxis, severe hypersensitivity, or significant swelling) to any medication
• People with significant heart rhythm abnormalities on an ECG, or abnormal vital signs such as blood pressure, heart rate, breathing rate, or blood oxygen levels outside specified ranges at screening
• People with a history of drug misuse in the year before screening
• People with a history of alcohol misuse in the year before screening, or regular alcohol use in the month before screening that exceeds 10 units per week (where one unit equals 375 mL of regular beer, 100 mL of wine, or 30 mL of spirits)
• People with a history of active tuberculosis, or currently active or latent tuberculosis (note: previously treated latent tuberculosis that is no longer active does not automatically exclude someone — confirm with trial site)
• People with a history of serious opportunistic infections (infections that typically affect people with weakened immune systems), such as invasive fungal infections or a specific type of pneumonia (pneumocystis pneumonia)
• People who have had a serious localised infection (such as a severe skin infection or abscess) or a body-wide infection (such as blood poisoning) in the 3 months before screening
• People who have had a fever above 37.5°C in the 2 weeks before dosing
• People who have used certain medications within specified timeframes (confirm with trial site for the full list)
• People who have taken part in another clinical trial involving an investigational or approved drug or device within 30 days before the first dose, or a biological product trial within 90 days before the first dose, or who are currently taking part in another investigational study
• People who have donated plasma within 7 days before dosing, or donated or lost 500 mL or more of blood within 8 weeks before dosing
• People whom the trial investigator believes, for any reason, would not be suitable to participate

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