Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Single-dose Study of BMS-986326 at Two Dose Levels in Participants with Atopic Dermatitis

This study is researching a new medicine called BMS-986326 for people who have eczema, also known as atopic dermatitis. It's an early-stage study, meaning it's one of the first times this medicine is being tested in humans. The main goal is to understand how a single dose of this medicine works in the body and how it is handled at two different dose levels. This helps researchers learn about the medicine's safety and how it moves through your system. Participants will be adults aged 18 and over, and both men and women can take part. This type of study is important for gathering basic information about new treatments before they are tested in larger groups of people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

11 Sep 2023

Atopic Dermatitis

What is this study about?

This study is investigating an experimental medicine called BMS-986326 designed for people with eczema, which doctors call atopic dermatitis. Eczema is a common skin condition that makes your skin red, itchy, and dry.

The main purpose of this particular study is to learn more about how a single dose of the new medicine, BMS-986326, acts in the body. Researchers want to understand things like how much of the medicine gets into the bloodstream, how quickly it leaves the body, and if it causes any side effects. They are testing two different dose levels to see if there are any differences. This type of study is called a 'Phase I' study and is a very early step in testing new medicines.

Learning about how a new medicine works in the body is really important. It helps scientists decide if it's safe to test in more people and if it could potentially be a useful treatment for eczema in the future. By taking part, you would be helping medical researchers understand this new medicine better.

Key takeaways

This study is testing a new medicine (BMS-986326) for eczema.
It's an early-stage study to understand how a single dose works in the body.
Participants must be 18 years or older, both men and women can join.
Taking part helps medical research and could lead to future treatments.
Your health would be closely monitored by a medical team.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit, so people of all adult ages can take part.

Both men and women are welcome to participate in this research. The study needs a mix of people to get a good understanding of how the medicine works.

The specific details of your eczema would be carefully reviewed by the study team. They would check your medical history to make sure that taking part in the study would be safe and appropriate for you.

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 eczema (atopic dermatitis)?
Are you willing to attend multiple clinic visits?
Are you able to follow study instructions carefully?
Are you generally healthy, apart from your eczema, (this will be checked by the study doctor)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to make sure you are suitable. If you qualify, you would receive a single dose of the study medicine. This would be observed closely by the study team.

After receiving the medicine, you would need to attend several follow-up visits over a certain period. During these visits, the study team would check your health, take blood samples, and ask about any changes you might have noticed. This helps them understand how the medicine is working and if you are experiencing any side effects.

The exact number and duration of visits would be explained in full by the study team, but typically, these early-stage studies can involve several visits over a few weeks to monitor you closely.

Potential risks and benefits

Participating in research studies like this helps advance medical knowledge and could potentially lead to new treatments for eczema in the future. While this study is not primarily designed to improve your eczema directly, there's always a chance you might experience some impact from the medicine. However, as with all new medicines, there's a risk of side effects, which could be mild or more serious. The research team will explain all known risks and closely monitor you throughout the study. Remember, taking part is completely voluntary, and you can change your mind and withdraw from the study at any time without affecting your usual medical care.

Locations (5)

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

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Unverified
Czechia
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Unverified
Germany
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Unverified
Spain
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Unverified
France
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Unverified
Poland

Common questions

What is atopic dermatitis?

Atopic dermatitis is another name for eczema, a common skin condition that causes red, itchy, and dry skin.

What does a 'single-dose study' mean?

It means you would receive the study medicine only once, not repeatedly over time. The researchers then observe its effects.

What is a 'Phase I' study?

This is an early stage of research where a new medicine is tested in people for the first time. The main goal is to check its safety and how it works in the body.

Will this medicine cure my eczema?

This study is too early to tell if the medicine will cure eczema. It's mainly to understand how the medicine behaves in the body.

Do I have to stop my current eczema treatments?

This is something you would need to discuss with the study doctor, as it depends on the specific rules of the trial.