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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03962998

NCT03962998
Completed Early Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are over 18 years old and are male, or a female who is not pregnant or breastfeeding
  • You are willing to follow all the study requirements and have signed a consent form
  • Your heart tracing (ECG) test at the start of the study is normal or not a concern, in the opinion of the study doctor
  • Your kidneys are working well enough, based on a blood test measuring kidney function (confirm with trial site)
  • You agree not to take anti-inflammatory painkillers (such as ibuprofen or naproxen) until the study is finished

For people with Crohn's disease, you may also need to meet these requirements:

  • You have been diagnosed with active Crohn's disease affecting the small bowel, confirmed by a special MRI scan done within one month before joining
  • Your Crohn's disease shows certain active signs in the bowel, such as inflammation, thickening of the bowel wall, or increased blood flow (confirm with trial site)

Who may not be able to join:

  • Women who are pregnant, breastfeeding, planning to become pregnant, or not willing to use a reliable form of birth control during the study; men must also be willing to use contraception or abstain from sex from the dosing day until at least 7 days after
  • You have taken part in another clinical trial within the last 30 days, or are currently in another medical research study that could affect the results
  • You are unable to go without food overnight (fasting)
  • You have taken anti-inflammatory painkillers (like ibuprofen) within 14 days before the study starts
  • You have had a problem with drug or alcohol misuse in the past year
  • You have been diagnosed with ulcerative colitis, indeterminate colitis, pseudomembranous colitis, or celiac disease
  • You have been diagnosed with an autoimmune disease (a condition where the immune system attacks the body)
  • You have had surgery on your digestive system, including appendix removal, within 12 weeks before joining, or surgery is planned during the study
  • You have Type 1 or Type 2 diabetes
  • You have a history of severe allergic reactions or anaphylaxis to any substance, including medicines, or to the study drug MB-102
  • You have a known history of HIV or AIDS
  • You work at the study site or are an immediate family member of someone who does
  • The study doctor feels, for any reason, that joining the trial would not be right for you
  • You have previously received the study drug MB-102
  • Your regular medications have changed between the first and second testing days
  • You currently have a urinary tract infection
  • Your body mass index (BMI) is over 30 (confirm with trial site if you are unsure of your BMI)
  • You have a history of cancer in the small bowel or have had surgery to remove part of the small bowel
  • You are unable to attend study visits that last 12 hours or more

For people without Crohn's disease, you also may not be able to join if:

  • You have had a fecal (stool) transplant within the past year
  • You have or have had graft-versus-host disease (a condition sometimes seen after transplants)
  • You have or have had diverticulitis (inflammation of pouches in the bowel)
  • You have or have had a fatty liver
  • You are currently taking certain medicines, including biologic therapies, steroids, immune-suppressing drugs, or anti-diarrhoea medicines (confirm with trial site for the full list)
  • You have taken antibiotics within 30 days before joining
  • You have ongoing unexplained digestive problems or food intolerances
  • You have recently had unexplained significant weight loss, blood in your stool, or severe episodes of diarrhoea
  • A close family member (parent, sibling, or child) has been diagnosed with inflammatory bowel disease
  • You have a history of Crohn's disease

For people with Crohn's disease, you also may not be able to join if:

  • You are currently being fed through a drip directly into a vein (called Total Parenteral Nutrition or TPN)

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Early Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Early Phase 1
Sponsor
MediBeacon
Registry
clinicaltrials_gov
Start date
27 October 2019
Est. completion
5 October 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov