Phase 2 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:

For Parts A and B (healthy volunteers, ages 18–55):

• You are between 18 and 55 years old
• You are in good general health with no significant medical history
• Your routine blood and lab test results are within the normal range
• Your Body Mass Index (BMI) is between 18 and 35
• You are willing to use contraception as required by local guidelines (applies to both men and women)
• You are able and willing to sign a consent form agreeing to take part

For Part C (patients with ulcerative colitis, ages 18–75):

• You are between 18 and 75 years old
• You are in good general health aside from your ulcerative colitis
• You have been diagnosed with ulcerative colitis for at least 3 months before the screening visit
• Your ulcerative colitis is currently moderately to severely active, based on specific scoring measures (confirm with trial site)
• Your ulcerative colitis affects a significant portion of your colon, confirmed by a colonoscopy at screening (confirm with trial site)
• Previous treatments for ulcerative colitis have not worked well enough, have stopped working, or you were unable to tolerate them
• You are able and willing to sign a consent form agreeing to take part

Who may not be able to join:

For Parts A and B:

• You have any physical or mental health condition that would prevent you from completing the study
• You have a history of suicidal thoughts or behavior
• You are a heavy user of nicotine-containing products (e.g., cigarettes, vapes)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• You have an irregular heartbeat or an abnormal heart tracing (ECG)
• You have used prescription medications in the 14 days before the study starts
• You have used any over-the-counter or herbal medicines in the 7 days before screening
• You have taken part in another clinical trial within the last 30 days
• You have donated blood or plasma within the last 60 days
• You are pregnant or breastfeeding

For Part C:

• You have any physical or mental health condition that would prevent you from taking part in the study
• You have been diagnosed with Crohn's disease or another type of colitis other than ulcerative colitis (such as microscopic, ischemic, infectious, or radiation-related colitis)
• You have tested positive for a gut infection called Clostridioides difficile (C. diff)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• You have an irregular heartbeat or an abnormal heart tracing (ECG)
• You are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying. Additional criteria not listed here may also apply.