AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma

This is a very early study looking at a new potential medicine called BBT002. It's designed for adults who have ongoing lung problems like Chronic Obstructive Pulmonary Disease (COPD) or asthma, or a condition affecting the nose and sinuses called Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The main goals are to find out if the new medicine is safe for people to take and if their bodies handle it well. Researchers will also be checking to see what effects it has on the body and if there are any signs that it could help these conditions. This is one of the first times this medicine will be given to people.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bambusa Therapeutics Inc.

Enrolment target

Start

16 Feb 2026

Chronic Obstructive Pulmonary Disease (COPD) Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Comorbid Asthma

What is this study about?

This study is about a new medicine, BBT002, that doctors are looking into for a few different long-term health conditions. These conditions include Chronic Obstructive Pulmonary Disease (COPD), which makes it hard to breathe, asthma, which affects breathing, and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), a condition that causes stuffy noses and sinus problems due to growths called polyps.

Because this is a very early-stage study, known as Phase 1, the main focus is on carefully checking a few key things. Firstly, the team wants to understand if the medicine is safe for people to take and how well their bodies cope with it. They will also look at how much of the medicine stays in the body and for how long. Secondly, they'll be checking to see what the medicine does inside the body and if it has any noticeable effects on the conditions themselves.

It’s important to remember that this is an exploratory study. This means doctors are gathering foundational information to see if this new medicine has promise. The results from studies like this help decide if a medicine should be tested further in larger groups of people, hopefully leading to new and better treatments in the future.

Key takeaways

This study is testing a new medicine (BBT002) for the first time in people.
It's for adults with COPD, CRSwNP, or asthma.
The main goals are to check the medicine's safety and how the body handles it.
Participants will have regular health checks and take the study medicine.
This research aims to find better treatments for these conditions in the future.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Specifically, you would either need to be a healthy volunteer (someone without these conditions) or have one of the conditions being studied: Chronic Obstructive Pulmonary Disease (COPD), Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), or asthma that occurs alongside one of the other conditions.

There will be other detailed health checks and rules to make sure the study is safe and the results are clear. Your study doctor can explain these to you.

Quick self-check

Are you 18 years old or older?
Do you have COPD?
Do you have Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)?
Do you have asthma (and possibly another of these conditions)?
Are you willing to attend regular study visits?

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

What does participation involve?

If you decide to take part, you'll visit the study clinic regularly. At these visits, doctors and nurses will check your health through blood tests, physical exams, and possibly other tests related to your condition. You will be given the study medicine, BBT002, usually for a set period. After taking the medicine, there will be follow-up visits to see how you are doing and track any changes. The total time you'd be involved in the study will depend on the specific part of the study you join, but it will be explained fully before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit, but your involvement could help researchers learn more about new medicines, potentially helping others in the future. As this is a new medicine, there's a chance of side effects that aren't fully known yet. The study team will explain all known potential risks before you decide to join. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Poland

Common questions

What is a 'Phase 1' study?

A Phase 1 study is a very early step in testing a new medicine. It mainly checks if the medicine is safe for people and how their bodies handle it.

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe.

What is CRSwNP?

CRSwNP means Chronic Rhinosinusitis with Nasal Polyps. This is a condition where you have ongoing stuffiness and problems in your nose and sinuses because of growths called polyps.

Will this medicine cure my condition?

It's too early to say if this medicine will cure any condition. This study is mainly about safety and understanding the medicine better.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical study. All study-related care and medicine are usually provided free of charge.