A study to investigate the safety, tolerability, and pharmacokinetics of Ent001 in patients with moderately to severely active ulcerative colitis
This research is testing a new medicine, Ent001, for adults in the UK who have ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation in the large bowel. This specific study is for people whose colitis is active and causing moderate to severe symptoms. Researchers want to understand if Ent001 is safe to use and if people can take it without too many problems. They are also looking at how the body processes the medicine – how it's absorbed, distributed, and eventually leaves the body. This is a very early stage of testing for a new medicine, focusing on these important safety and body-response questions before looking at how well it treats the condition.
At a glance
What is this study about?
This study is about a new medicine called Ent001, which is being investigated for people living with a condition known as ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. This particular study is for adults whose ulcerative colitis is currently active and causing quite severe symptoms.
The main aim of this research is to check the safety of Ent001. When a new medicine is developed, the first priority is always to make sure it's safe for people to take. Researchers will be looking for any side effects and how well people tolerate the medicine, meaning if they can take it without experiencing too many uncomfortable feelings. They will also be studying how the body handles Ent001 – for example, how much of it gets into the blood, how it moves around the body, and how quickly the body gets rid of it. This information is very important for understanding how the medicine works.
This is an early-stage study, sometimes called a 'Phase I' study. This means it's one of the first times this medicine is being given to people, and the focus is on understanding basic safety and how the medicine behaves in the human body, rather than how effective it is at treating the condition. The results of this study will help decide if it's safe and sensible to continue testing Ent001 in further, larger studies to see if it can effectively treat ulcerative colitis.
Key takeaways
- This study is testing a new medicine called Ent001 for ulcerative colitis.
- It's for adults (18+) with moderately to severely active ulcerative colitis.
- The main goals are to check the medicine's safety and how the body handles it.
- This is an early-stage study, focusing on understanding the new medicine's basic information.
- Participation involves clinic visits, assessments, and close monitoring.
- You can stop taking part at any time.
Who may be eligible?
This study is looking for adults aged 18 years and older. There is no upper age limit, so older adults can also be considered.
To be included, you would need to have ulcerative colitis that is currently active and causing moderate to severe symptoms. Both men and women are welcome to take part in this research.
There might be other specific health requirements or conditions that mean you can't join the study, even if you meet the main criteria. If you are interested, a study doctor will discuss all the details with you to see if the study is a good fit for your personal health situation.
- Are you 18 years old or older?
- Do you have ulcerative colitis?
- Is your ulcerative colitis currently active and causing moderate to severe symptoms?
- Are you willing to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the new medicine, Ent001. This study involves a series of visits to the clinic where the research takes place. During these visits, the study team would perform various assessments. This might include physical examinations, blood tests, and other checks to see how you are responding to the medicine and to monitor your general health. You would also be asked questions about any symptoms you're experiencing and how you're feeling.
The visits are designed to carefully monitor your progress and ensure your safety throughout the study. After receiving the medication, there will be follow-up appointments to track your health over a certain period. The total time you would be involved in the study would depend on the specific plan but would be explained clearly to you before you agree to take part.
Potential risks and benefits
Locations (4)
- —Romania
- —Netherlands
- —Bulgaria
- —Hungary
Common questions
What is ulcerative colitis?
It's a long-term condition that causes inflammation and sores in the lining of your large bowel.
What does 'moderately to severely active' mean?
It means your ulcerative colitis symptoms are currently quite challenging and noticeable.
What is the purpose of this study?
It's mainly to check if the new medicine, Ent001, is safe and how your body handles it.
Is this medicine available to everyone?
No, it's a new medicine being tested in a study, so it's not generally available yet.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time without affecting your normal healthcare.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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