Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b Study to Characterize the Safety and Tolerability of TEV-53408 in Adults with Celiac Disease

This research study is about a new drug called TEV-53408, which is being investigated for adults who have coeliac disease. It's one of the first studies involving people, known as a Phase 1b trial. The main goal at this stage isn't to see if the medicine cures coeliac disease, but to carefully check if it's safe to use and how the body reacts to it. Researchers will be looking out for any side effects and trying to understand how much of the drug someone can take without experiencing problems. This kind of early study is an important step in developing new treatments, providing vital information before moving on to larger trials that test how effective the medicine is.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Enrolment target

Start

19 Oct 2023

Celiac disease

What is this study about?

Imagine you have coeliac disease, and your body reacts badly to gluten, causing damage to your gut. Scientists are always trying to find new ways to help people with this condition. This particular study is an early step in that journey, focusing on a new medicine called TEV-53408.

This study is called a 'Phase 1b' trial. In simple terms, it means it's one of the very first times this specific medicine is being given to people. The main purpose of these early studies isn't to see if the medicine works to reduce your symptoms or heal your gut, but to find out if it's safe and if your body can cope with it without too many problems. The researchers will be very carefully watching participants for any side effects and trying to figure out the right amount of the medicine to give.

Gathering information on safety and how the body handles the medicine is incredibly important. If a medicine isn't safe, it can't move forward to bigger studies that look at whether it actually helps treat the disease. So, while this study might not directly improve your coeliac symptoms, it's a crucial part of the process that could, in the future, lead to new and better treatments for coeliac disease.

Key takeaways

This study is testing a new medication (TEV-53408) for coeliac disease.
It's an early-stage (Phase 1b) trial, focusing on safety and how the body handles the drug.
Participants must be adults (18 years or older) with coeliac disease.
Both men and women can take part.
Taking part helps science and might lead to future treatments for coeliac disease.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults who have coeliac disease. To join, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other health requirements.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of adults to see how the new medication might affect different people.

Even though the details aren't fully listed here, typically, being eligible for a study like this also means you'll need to be generally healthy apart from your coeliac disease, and you might have certain medical tests to make sure it's safe for you to take part.

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 18 years old or older?
Do you have coeliac disease?
Are you generally well apart from your coeliac disease?
Are you willing to attend regular appointments?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this usually involves several visits to a clinic or hospital over a period of time. You'd likely receive the new medication, TEV-53408, and have regular check-ups to see how you're feeling and if you're experiencing any side effects. These check-ups might include blood tests, physical examinations, and answering questions about your health and any symptoms you have. The exact number of visits, how long each visit lasts, and the total duration of the study would be explained in full detail by the research team. After taking the medication, there would probably be a follow-up period where your health continues to be monitored even if you're no longer taking the study drug.

Potential risks and benefits

Participating in a study like this means you're helping advance medical understanding of coeliac disease, which could benefit others in the future. While this is an early-stage study, there's always a chance you might personally benefit from the new medication, though that's not the main goal. However, there are potential risks, as with any new medication. You might experience side effects, some of which could be mild, like an upset stomach, or more serious. The research team will monitor you very closely for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Finland

Common questions

What is coeliac disease?

Coeliac disease is a serious autoimmune condition where your body reacts to gluten (a protein found in wheat, barley, and rye), causing damage to the lining of your small intestine.

What does 'Phase 1b' mean?

Phase 1b means this is one of the very first times the new medicine is being tested in people. The main focus is on safety and how the body handles the drug, rather than how well it treats the illness.

Will this medicine cure my coeliac disease?

The main goal of this early study is to check for safety and side effects, not to see if it cures coeliac disease. It's a first step, and if safe, it might lead to studies that look at its effectiveness later.

Will I get paid to be in the study?

Sometimes studies offer payment for your time and travel, but this varies. You would need to ask the research team directly about any compensation or expenses covered.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without needing to explain why, and it won't affect your regular medical care.