Early 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:

For all participants:

• People aged 18 to 75 years at the screening visit
• People with a body mass index (a measure of body weight relative to height) between 19 and just under 40
• People willing and able to sign a consent form and follow all trial procedures
• Women who could become pregnant must agree to use a highly effective form of contraception (such as hormonal birth control, an intrauterine device, or complete abstinence if that is their normal lifestyle) starting at least 2 weeks before the imaging procedure and for at least 1 week after; they must also avoid donating eggs for 3 months after the imaging procedure
• Male participants must agree to use a condom, be vasectomised, or abstain from heterosexual intercourse (if that is their normal lifestyle) from the imaging procedure until 3 months after, and their female partners who could become pregnant must also use highly effective contraception

For Cohort 1 — Healthy volunteers:

• People in generally good health with no significant medical history, abnormal physical findings, heart tracing results, or abnormal blood test results, as assessed by the trial doctor

For Cohort 2 — People with suspected liver disease (MASH diagnosed without biopsy):

• People with evidence of fat build-up in the liver confirmed by biopsy, imaging, or a specialised scan within the past 24 weeks
• People who meet at least one of the following health markers: higher body weight or waist size; elevated fasting blood sugar, blood sugar after a meal, or a long-term blood sugar measure; a diagnosis of or treatment for type 2 diabetes; high blood pressure or blood pressure medication; elevated blood fats or cholesterol-lowering medication; or low "good" cholesterol levels or cholesterol-lowering medication
• People with a blood marker of liver scarring activity (ProC3) at or above 12.6 ng/mL

For Cohort 3 — People with confirmed liver disease (MASH diagnosed by biopsy):

• People with evidence of fat build-up in the liver confirmed by biopsy, imaging, or specialised scan within the past 24 weeks
• People who meet at least one cardiometabolic health marker from the same list described for Cohort 2
• People with a historical liver biopsy taken between 4 and 24 weeks before joining that confirmed a specific type of liver disease (metabolic dysfunction-associated steatotic liver disease)
• People with a blood marker of liver scarring activity (ProC3) at or above 12.6 ng/mL

For Cohort 4 — People with a specific type of Crohn's disease (fibrostenotic CD):

• People with confirmed narrowing of the bowel related to Crohn's disease, shown by MRI or colonoscopy within the past 24 weeks
• People with a low Crohn's disease activity score (below 150), a low gut inflammation marker (calprotectin below 250), and a low general inflammation marker (CRP below 20)

For Cohort 5 — People with a specific liver and bile duct condition (PSC):

• People with confirmed large-duct primary sclerosing cholangitis (a condition causing scarring of the bile ducts), shown by a specialised scan (MRI/MRCP)
• People with a blood marker of liver scarring activity (ProC3) at or above 12.6 ng/mL

Who may not be able to join:

• People who cannot have an MRI scan for any reason, including claustrophobia, certain metal implants or internal electrical devices (such as pacemakers, cochlear implants, nerve stimulators, aneurysm clips, or artificial heart valves), inability to lie flat for 90 minutes, or permanent makeup or tattoos that may cause safety concerns (confirm with trial site)
• People who have worked as a metal worker or welder
• People with a significant medical condition or history that the trial doctor believes could affect their safety or the trial results
• People who have had a significant illness, medical procedure, or injury within 4 weeks of the screening visit
• People diagnosed with cancer in the past 12 months, except for certain successfully treated skin cancers or prostate cancer under monitoring with no procedures planned during the trial
• People with a major surgery planned during their time in the trial
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People who test positive for hepatitis B, hepatitis C, or HIV at the screening visit
• People with a chronic active infection such as HIV, hepatitis B or C, or tuberculosis
• People with poor vein access, as assessed by the trial doctor
• People whose blood pressure or pulse falls outside specified safe ranges after resting for 10 minutes at the screening visit
• People whose body weight has changed by 5% or more in the 3 months before the screening visit
• People with abnormal blood test results that the trial doctor believes could affect safety or trial results
• People with a significantly abnormal heart tracing (ECG) or heart symptoms, as assessed by the trial doctor
• People currently taking medications that are not permitted under the trial protocol, as determined by the trial doctor
• People using hormone therapies at doses that may interfere with the trial measurements, as assessed by the trial doctor (stable hormone replacement therapy is generally permitted)
• People currently participating in another clinical trial, or who participated in one within the past 30 days, or who took part in another PET imaging trial within the past 12 months
• People who test positive for alcohol at the screening visit (applies to Cohort 1 only)
• People with a history of or ongoing alcohol misuse or excessive alcohol intake, as assessed by the trial doctor
• People with a history of or current drug misuse, as assessed by the trial doctor
• People with a history of or current use of anabolic steroids, as assessed by the trial doctor
• People who have donated plasma within the past month or blood within the past 3 months
• People the trial doctor believes are unlikely to follow the trial procedures and requirements

Additional criteria for Cohorts 2–5 (disease-related groups):

• People taking vitamin E, a type of diabetes medication called thiazolidinediones, or GLP-1 receptor agonists (a type of diabetes or weight medication), unless they have been on a stable dose for at least 3 months before screening and will continue that dose throughout the trial
• People whose long-term blood sugar measure (HbA1c) is at or above a certain level at screening without a prior diagnosis of type 2 diabetes; people with type 2 diabetes may still be considered if their diabetes treatment has been stable for at least 3 months, but those with a very high HbA1c (at or above 63 mmol/mol / 9%) at screening will be excluded
• People with a significant health condition other than type 2 diabetes that the trial doctor believes may interfere with results or participant safety
• People with a severe immune or inflammatory condition (such as rheumatoid arthritis, psoriasis, multiple sclerosis, or similar); people with mild to moderate or inactive versions of these conditions may still be considered

Additional criteria for Cohorts 2, 3, and 5 (liver disease groups):

• People with a liver stiffness measurement above a certain threshold, or any signs of advanced liver decompensation, as measured by a specialised scan
• People with certain significantly abnormal liver, kidney, or blood clotting results during screening, including very high liver enzymes, high bilirubin, low platelet count, reduced kidney function, or a history of serious liver complications such as fluid accumulation, brain confusion related to liver disease, or bleeding from enlarged veins
• People whose body weight has changed by 5% or more since their qualifying liver biopsy

Additional criteria for Cohort 4 (Crohn's disease group):

• People whose MRI shows only active inflammation in the bowel, without the narrowing (fibrosis) required for this cohort

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