Active not recruitingPHASE1INTERVENTIONAL

A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's Disease

This important study is testing a new drug called PALI-2108. It's for people with a specific form of Crohn's disease where the gut becomes scarred and narrow, making it hard for food to pass through. Doctors call this fibrostenotic Crohn's disease. The main goal is to understand how PALI-2108 works inside the body. We'll be looking closely at what happens to cells and tissues in the gut and blood after people take the drug for a short time. This will help us see if it can help reduce both inflammation and the scarring that causes narrowing. This study is a small, early-stage trial (Phase 1b), meaning we're learning a lot about the drug's effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Palisade Bio

Enrolment target

Start

17 Oct 2025

Estimated completion

15 Mar 2026

Fibrostenotic Crohn's Disease

What is this study about?

This study is a step towards finding better treatments for a specific type of Crohn's disease called fibrostenotic Crohn's disease. With this type of Crohn's, alongside the usual inflammation, the bowel also develops scarring and becomes narrow. This narrowing can cause serious problems, making it difficult for food to pass through and sometimes requiring surgery. Unfortunately, current treatments don't always tackle this scarring very well, so there's a real need for new medicines.

The drug being tested is called PALI-2108. It's designed to work by calming down inflammation and hopefully reducing the scarring process. This study is an 'exploratory' one, which means we're primarily focused on understanding how the drug works in the body at a very detailed level. We want to see what changes it causes in the cells and tissues of the gut, and also in the blood.

To do this, we'll be collecting tiny samples of bowel tissue (biopsies) and blood from participants before they start taking PALI-2108 and again after a short time on the drug. By looking at these samples very closely, we hope to learn if PALI-2108 can target the underlying problems in fibrostenotic Crohn's disease. This is part of a larger research effort that also includes looking at the drug in healthy volunteers and people with ulcerative colitis, another inflammatory bowel condition.

Key takeaways

This study is testing a new drug, PALI-2108, for fibrostenotic Crohn's disease.
It aims to understand how the drug affects inflammation and scarring in the gut.
Participants will take the drug for 14 days and have biopsies and blood tests.
This is an early-stage study, focused on understanding the drug's effects.
The goal is to find better ways to treat tough-to-manage Crohn's symptoms.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 60 years old and have a body mass index (BMI) within a specific range (between 18.5 and 30.0 kg/m2). You should also be a non-smoker or have quit smoking.

It's important that you are generally healthy, apart from your fibrostenotic Crohn's disease. The doctors will check your medical history, do a physical exam, and measure your vital signs (like blood pressure) and heart tracing (ECG) to make sure there are no other significant health issues.

If you are a woman of childbearing age, or a man whose partner could become pregnant, you would need to agree to use effective birth control methods during the study and for a period afterwards. This is to ensure the safety of any potential future pregnancies, as we don't yet know the drug's effects on unborn babies.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Do you have fibrostenotic Crohn's disease?
Are you a non-smoker or ex-smoker?
Are you generally healthy, aside from your Crohn's?
Are you willing to use effective contraception if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would take the study drug PALI-2108 by mouth once a day for 14 days. Before you start, and again after 14 days of treatment, you would have some key assessments. These include having small pieces of your bowel tissue taken (called pinch biopsies) and providing blood samples. These samples help the researchers understand how the drug is working at a cellular level. Throughout the study, your safety will be carefully monitored, and there will be checks on how well your body processes the drug.

Potential risks and benefits

Potential benefits of taking part include contributing to important medical research that could lead to new treatments for fibrostenotic Crohn's disease. You would also receive close medical attention during the study. Potential risks are generally associated with taking a new, experimental drug, and could include side effects, although these are unknown at this early stage. There are also risks linked to procedures like biopsies and blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Altasciences
Verified postcode
Montreal, Canada

Common questions

What is PALI-2108?

PALI-2108 is a new experimental drug being investigated for its potential to reduce inflammation and scarring in conditions like Crohn's disease.

What is fibrostenotic Crohn's disease?

It's a type of Crohn's disease where, in addition to inflammation, the bowel walls become scarred and narrow, which can cause blockages.

How long will I take the study drug?

You would take the study drug, PALI-2108, once a day by mouth for 14 days.

Will I have to have biopsies?

Yes, small pieces of bowel tissue (pinch biopsies) will be taken at the start and end of the 14-day treatment period.

Is this study only for people with Crohn's disease?

This specific part of the study is for people with fibrostenotic Crohn's disease, but the drug is also being looked at in healthy volunteers and people with ulcerative colitis as part of a larger project.