Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

PET study of changes in [11C]AZ14132516 uptake following administration of multiple AZD7798 doses to patients with Crohn’s disease.

This study is for people living with Crohn's disease. Researchers want to understand how a new investigational medicine, called AZD7798, works in the body. They will use a type of scan, called a PET scan, to look at changes in how a special marker, [11C]AZ14132516, shows up in the body after participants receive multiple doses of AZD7798. This is an early-stage study, meaning it's primarily focused on learning more about how the drug behaves and if it's safe at different doses. The goal is to gather important information that could help develop better treatments for Crohn's disease in the future. It's a key first step in understanding this new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

25 Jul 2024

Crohn's disease

What is this study about?

This study is looking into a new medicine called AZD7798 for people who have Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in your digestive system. Researchers want to find out how this new medicine works inside the body when given multiple times. This is really important because understanding how a medicine affects the body can help scientists develop more effective treatments.

To do this, they will use a special imaging technique called a PET scan. During the scan, they will look at something called [11C]AZ14132516, which acts like a signal or marker in the body. By looking for changes in this marker after participants take the new medicine, researchers hope to learn how AZD7798 is interacting with the body and what effects it might be having. This helps them learn if the medicine is reaching the right places and having the desired impact.

This is an early-stage study, often called a Phase 1 study, which means it's one of the first times this medicine is being tested in people. The main goals at this stage are usually to check if the medicine is safe, to understand how the body handles it, and to see if there are any early signs that it might work. All this information is crucial for future research and potentially developing new medicines to help people with Crohn's disease.

Key takeaways

This study is testing a new medicine (AZD7798) for Crohn's disease.
It uses special scans (PET scans) to see how the medicine works in the body.
It's an early-stage study, focusing on safety and how the medicine behaves.
You must be 18 or older and have Crohn's disease to be considered.
Both men and women can participate.
Participation involves regular clinic visits and careful monitoring.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit mentioned, meaning older adults can also be considered.

This study is specifically looking for people who have been diagnosed with Crohn's disease. Both men and women are welcome to participate.

There might be other health requirements or conditions that mean you can or cannot join, but these details are not available here. A doctor on the study team would need to check your full medical history to see if it's right for you.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Crohn's disease?
Are you able to attend appointments at the study clinic?
Are you comfortable with the idea of having PET scans?
Are you willing to take an investigational medicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

We don't have all the specific details here about what your participation would involve, but generally, early-stage studies like this usually require several visits to the study clinic or hospital. These visits would likely include medical check-ups, blood tests, and receiving doses of the study medicine, AZD7798. You would also have PET scans at certain times to see how the medicine is affecting you. There will be careful monitoring by the study team, and you'd likely have follow-up appointments after your last dose. The overall length of time you'd be involved in the study is not specified but early stage trials can range from a few weeks to several months.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as contributing to new knowledge that might help people with Crohn's disease in the future, and you would receive careful medical attention during the study. However, there are also potential risks; the new medicine, AZD7798, is still being investigated and could have side effects that are not yet fully known. There are also risks associated with PET scans, such as exposure to a small amount of radiation. You will be fully informed of all known risks and benefits before deciding to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Sweden

Common questions

What is Crohn's disease?

Crohn's disease is a condition that causes long-lasting inflammation in your digestive system.

What is AZD7798?

AZD7798 is a new investigational medicine that researchers are studying to see how it works in people with Crohn's disease.

What is a PET scan?

A PET scan is a special type of medical imaging that helps doctors see how your organs and tissues are working, by using a small amount of a radioactive substance.

Why are they studying [11C]AZ14132516?

[11C]AZ14132516 is a special marker that helps researchers see how the medicine AZD7798 affects your body using the PET scan.

How long will the study last?

The information provided here doesn't state the exact duration, but early-stage studies can last from a few weeks to several months.