AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

BBT001 in Healthy Volunteers and in Adult Patients with Atopic Dermatitis

This research is looking into a new treatment called BBT001 for a skin condition called atopic dermatitis, also known as eczema. This is a very early stage (Phase 1) study, which means it's one of the first times this new medicine is being given to people. Scientists want to understand how BBT001 affects the body, what dose is best, and if it has any side effects or safety concerns. The study will involve both healthy volunteers and adults who have eczema. The aim is to gather important information to see if this new medicine has the potential to help people with eczema in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bambusa Therapeutics Inc.

Enrolment target

Start

21 Nov 2025

Atopic Dermatitis

What is this study about?

This study is about a new medicine called BBT001, which is being investigated as a possible treatment for a common skin condition known as atopic dermatitis, or eczema. Eczema can make your skin red, itchy, dry, and cracked, and it can be uncomfortable and frustrating for many people.

Because BBT001 is a new medicine, this study is a very early step in its development. It's called a 'Phase 1' study. This means it's one of the first times the medicine will be given to people. The main goals at this stage are to understand how the medicine behaves in the human body, how much is needed, and to check if it's safe. It will involve both healthy people and adults who have eczema, allowing researchers to compare how the medicine affects different groups.

If this initial study shows that BBT001 is safe and acts in the body as expected, it could then move on to bigger studies. These larger studies would aim to see if the medicine actually helps improve eczema symptoms. So, this first step is crucial for deciding if BBT001 has the potential to become a useful treatment option for people living with eczema in the future.

Key takeaways

This is an early study of a new eczema medicine, BBT001.
It aims to find out if BBT001 is safe and how it works in the body.
The study includes both healthy adults and adults with eczema.
Participation involves clinic visits and careful monitoring.
You can withdraw from the study at any time.
It's not yet known if BBT001 will be an effective treatment.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.

Part of the study will involve healthy volunteers, meaning people who don't have eczema or other significant health problems that could affect the study results. Another part will involve adults who have been diagnosed with atopic dermatitis (eczema).

The research team will have specific health checks and criteria to make sure it's safe for you to take part and that the study results are clear. These will involve looking at your overall health and any other medications you might be taking.

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 atopic dermatitis (eczema), or are you a healthy adult?
Are you able to attend regular clinic visits?
Are you comfortable potentially taking an experimental medicine?
Do you understand that this is a research study, not a guaranteed treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the clinic. During these visits, the study team will carry out health checks, which might include blood tests, urine tests, physical examinations, and measuring your vital signs like blood pressure and heart rate. You will be given the study medicine, BBT001, according to a specific schedule, and the team will closely monitor how your body reacts.

Depending on the specific part of the study you join, you might need to stay at the clinic for certain periods or attend regular follow-up appointments. The total time you'd be involved in the study could vary, but the team will explain the full schedule of visits and assessments to you before you agree to participate. You'll also be asked to keep a diary or record at home about any symptoms or how you're feeling.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to medical understanding and potentially helping to develop new treatments for eczema in the future. For those with eczema, there's a chance the new medicine might help with your symptoms, though this is not guaranteed, especially in early-stage studies. However, there are also potential risks, as BBT001 is a new medicine and may have side effects that aren't yet fully known. These side effects could range from mild to more serious reactions, and the study team will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without 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
Poland

Common questions

What is atopic dermatitis or eczema?

It's a common skin condition that makes your skin red, itchy, dry, and sometimes cracked. It often flares up and then settles down.

What does 'Phase 1' study mean?

This is a very early stage of testing a new medicine. It means it's one of the first times it's given to people, mainly to check if it's safe and how it works in the body.

Will this medicine cure my eczema?

It's too early to say if BBT001 will cure eczema. This study is mainly about safety and understanding the medicine, not about whether it cures the condition.

Do I have to pay to join the study?

No, you don't have to pay to join a clinical trial. All study-related care and medicines are provided free of charge.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.