Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients with Ulcerative Colitis

This research is looking at a new medicine called SOR102, which might help people with ulcerative colitis. This is the very first time SOR102 is being given to people, so the main goal is to check that it is safe. Scientists will give different amounts of SOR102 to both healthy volunteers and people who have ulcerative colitis. They will carefully watch to see if anyone has side effects and how their bodies react to the medicine. This type of study, called a Phase I trial, is an important early step. If SOR102 is found to be safe, it could then be studied further to see if it actually improves the symptoms of ulcerative colitis. This trial aims to gather important information that could lead to new treatments for this condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Sorriso Pharmaceuticals Inc.

Enrolment target

Start

14 Jun 2024

Ulcerative colitis

What is this study about?

This study is about a new medicine, which we'll call SOR102, that doctors hope might help people living with a bowel condition called ulcerative colitis. Ulcerative colitis causes inflammation in the large intestine, leading to symptoms like tummy pain, diarrhoea, and tiredness. Finding new and effective treatments is really important for people with this condition.

Because SOR102 is a very new medicine, this study is the first time it will be given to people. This means the most important thing the researchers want to find out is how safe it is. They will give SOR102 to a small number of healthy people and people with ulcerative colitis. The healthcare team will then carefully watch them for any changes or side effects, and see how the medicine behaves in their bodies.

This type of research is called a 'Phase I' trial. It's a crucial early step in developing any new medicine. If SOR102 is found to be safe in this study, it can then move on to bigger studies where doctors will explore more deeply whether it actually helps improve the symptoms of ulcerative colitis. The information gathered here will help decide if SOR102 has the potential to become a new treatment option for patients.

Key takeaways

New medicine (SOR102) being tested for ulcerative colitis.
First time in humans; main goal is to check safety.
Includes both healthy volunteers and people with ulcerative colitis.
Close monitoring for side effects and how the body reacts.
A key early step towards potentially new treatments.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. This study is open to both men and women.

Part of the study involves healthy people, which means you wouldn't have ulcerative colitis but would be willing to try the new medicine under close supervision. Another part of the study includes people who have been diagnosed with ulcerative colitis.

The research team will have a full list of specific health checks you'd need to pass to make sure it's safe for you to take part. For example, they'll check your general health, any other medicines you take, and if you have any other medical conditions.

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.

Am I 18 years old or older?
Am I male or female?
Do I have ulcerative colitis, or am I generally healthy?
Am I willing to attend regular appointments and be closely monitored?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have screening appointments to check if you're suitable for the study. If you are, you would then be given the new medicine, SOR102. This would likely involve staying at a clinic for a short period while the doctors and nurses closely monitor you after you take the medicine.

They would regularly take blood samples, measure your blood pressure and heart rate, and ask you about how you're feeling to check for any side effects. You might have several follow-up appointments over a few weeks or months after taking the medicine so the team can continue to monitor your health and how your body handles SOR102. The total duration of your participation would be explained fully before you join.

Potential risks and benefits

Taking part in any study has potential risks. Because SOR102 is a new medicine, there might be side effects that are not yet known. The healthcare team will monitor you very closely for any changes, and you'll be able to ask questions at any time. A potential benefit is helping researchers understand more about ulcerative colitis and developing new treatments that could help many people in the future. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is ulcerative colitis?

It's a long-term condition where the large intestine (bowel) becomes inflamed, causing symptoms like stomach pain, diarrhoea, and tiredness.

What does 'Phase I' mean for a trial?

It means this is the very first time the new medicine is being given to humans, mainly to check if it's safe and how it acts in the body.

Will I get paid to participate?

Most studies don't pay for participation, but they usually cover your travel expenses and other costs related to attending appointments. This will be fully explained.

What is SOR102?

It's the name of the new medicine being tested in this study, which researchers hope might help treat ulcerative colitis.

Do I have to have ulcerative colitis to join?

No, this study is looking for both healthy volunteers and people who have ulcerative colitis.