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

A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of [11C]AZ14132516 Following Administration to Healthy Participants

This study is a very early step in researching a new, experimental substance called [11C]AZ14132516. It's a special type of study that involves healthy volunteers, not people with a specific illness. Researchers are using advanced scanning technology, called PET scans, to carefully watch how this substance moves through the body and where it attaches. They want to understand its 'biodistribution' – meaning where it goes – and its 'binding characteristics' – how well it sticks to certain targets in the body, specifically CCR9, which is a protein that plays a role in some diseases like Crohn's. The information gathered here will help scientists decide if this substance has the potential to be developed further for research or treatments related to conditions like Crohn's disease in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

AstraZeneca AB, AstraZeneca AB

Enrolment target

Start

03 Apr 2023

Crohn's disease

What is this study about?

Imagine scientists are developing a new kind of 'tracker' that could help them understand diseases better, especially conditions like Crohn's disease. This study is one of the very first steps in testing one of these new trackers, called [11C]AZ14132516. Think of it like a tiny, harmless dye that glows on special scans. The main goal of this study is to see where this dye goes in the body and how well it sticks to certain parts, specifically a protein called CCR9, which is linked to Crohn's.

This study is unique because it's a 'Phase 0' study, meaning it's extremely early and involves a very small amount of the substance, much less than what might be used for treatment. It’s also an 'open label' study, which means both the participant and the research team will know that the study substance is being given. They're not looking for any treatment effects here because participants are healthy and the amount of substance is so small. Instead, they’re just trying to get a clear picture of how it behaves inside the body.

Why does this matter? By understanding exactly where and how this substance binds, scientists can learn if it's a good tool to help them see what's happening inside the body in conditions like Crohn's disease, for example, to track disease activity or check how other medicines are working. It's an important step in developing new ways to study and potentially manage complex diseases in the future.

Key takeaways

It's a very early research study, not a treatment trial.
It involves healthy volunteers to understand a new substance.
Special scans (PET) are used to see how the substance moves and binds in the body.
The goal is to gather information that could help future research into conditions like Crohn's disease.
You won't receive direct health benefits, but you'll contribute to medical science.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. This study is looking for both men and women.

Because this is an early study, it's very important that you don't have any serious health problems that could affect how your body responds to the experimental substance or the scans. The research team will carefully check your health to make sure it's safe for you to take part.

Things like certain medications you might be taking, or other existing medical conditions, could mean you wouldn't be able to join. The study team will discuss all of these details with you during the screening process to make sure it's the right fit.

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?
Are you generally healthy and don't have any major ongoing medical conditions?
Are you willing to undergo PET scans?
Are you comfortable with receiving a small amount of an experimental substance?
Do you understand this study is for research, not for treating an illness?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit. This involves health checks, like blood tests, and a discussion about your medical history to make sure you're suitable for the study. If you pass the screening, you would then have at least one study visit where you would receive a very small amount of the experimental substance, [11C]AZ14132516, likely as an injection. Following this, you would have special scans, called PET scans, to see how the substance moves around your body and where it attaches.

There might be a second PET scan at a later time to see if anything changes. Throughout the study, the research team will regularly check on your health and any side effects you might experience. They will also look at your blood pressure and other vital signs. The total duration of your participation in the study, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

The main benefit of taking part in this study is contributing to scientific knowledge that could help in the future understanding and potential treatment of diseases like Crohn's. You would not personally receive any direct health benefits, as this is a very early exploratory study. Potential risks are generally mild and temporary, such as discomfort from injections, or very minor reactions to the experimental substance, which is given in tiny amounts. There's also a small amount of radiation exposure from the PET scans, similar to what you might get from other common medical scans. The research team will carefully monitor you for any side effects, and you are free to withdraw from the study at any time, for any reason, without it affecting your 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
Sweden

Common questions

What is a 'Phase 0' study?

It's a very early study in humans, using tiny amounts of an experimental substance to see how it acts in the body, before testing for treatment effects.

Will this study help my Crohn's disease?

No, this study is not designed to treat Crohn's disease. It's for healthy volunteers and aims to gather basic information for future research.

What is a PET scan?

It's a special type of scan that uses a small amount of a radioactive tracer to create detailed pictures of organs and tissues, showing how they are working.

Will I become radioactive?

You will have a very small, temporary amount of radiation from the tracer, which quickly leaves your body naturally. The study team will explain all safety measures.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any point, for any reason, and it won't affect your future medical care.