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New drug BBT002 aims to tackle COPD and chronic sinusitis in early trial

NCT ID NCT06944925

Disease control Sponsor: Bambusa Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new drug, BBT002, in healthy volunteers and people with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP). The trial is double-blind and placebo-controlled, meaning some participants get the drug and some get a dummy treatment. The main goal is to check safety and how the body handles the drug, with a secondary look at whether it helps symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BBT002
What this could lead to
If successful, BBT002 could become a new treatment option for people with COPD or chronic sinusitis with nasal polyps.
What could go wrong
This is an early phase 1 trial, so the main goal is safety, not effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 286 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G) 1. Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G) 2. Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G) 3. Negative pregnancy tests for women of childbearing potential 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers 6. Adequate contraception use (for men and women of childbearing potential) 7. No clinically significant abnormalities or history of relevant diseases Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70 Key Inclusion Criteria (Parts D and G) 1\. Participants with confirmed diagnosis of CRSwNP Key Exclusion Criteria for (Parts A, B, C, D, E, F, and G) 1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV) 2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections 3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders 4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function 5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1 6. Abnormal Electrocardiogram(ECG) findings 7. History of drug/alcohol abuse in the past 2 years 8. History of severe allergic reactions or hypersensitivity Key Exclusion Criteria (Part C and F only) 1. Current diagnosis of other significant pulmonary disease 2. Significant or unstable cardiovascular diseases 3. Recent clinically significant infection 4. Inability to perform spirometry Key Exclusion Criteria (Parts D and G) 1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP 2. Sinonasal surgery (recent/extensiv) 3. Consitions interfering with nasal assessments 4. Excluded sinonasal/systemic diseases

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aleksandre Aladashvili Clinic LLC

    RECRUITING

    Tbilisi, 0198, Georgia

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

    NOT_YET_RECRUITING

    Krakow, 31-011, Poland

  • Equity Medical - Owensboro

    NOT_YET_RECRUITING

    Owensboro, Kentucky, 42303, United States

  • Equity Medical Bowling Green

    RECRUITING

    Bowling Green, Kentucky, 42104, United States

  • Equity Medical LLC

    RECRUITING

    New York, New York, 10023, United States

  • Geo Hospitals Tbilisi Multiprofile Medical Center

    RECRUITING

    Tbilisi, 0198, Georgia

  • LEPL The First University Clinic of Tbilisi State Medical University

    RECRUITING

    Tbilisi, 0198, Georgia

  • Linear Clinical Research

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Ltd Aversi Clinic

    RECRUITING

    Tbilisi, 0198, Georgia

  • Momentum Clinical Research

    RECRUITING

    Brisbane, 4068, Australia

  • Momentum Clinical Research

    RECRUITING

    Pukekohe, 2120, New Zealand

  • Momentum Clinical Research

    RECRUITING

    Wellington, 6021, New Zealand

  • Momentum Clinical Research Hamilton

    NOT_YET_RECRUITING

    Rotorua, Hamilton, 3010, New Zealand

  • Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz

    NOT_YET_RECRUITING

    Gdansk, 80-214, Poland

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