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New drug BBT002 aims to ease sinus and asthma symptoms

NCT ID NCT07436949

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called BBT002 in healthy volunteers and people with chronic sinusitis, nasal polyps, and asthma. The main goal is to check the drug's safety and how the body processes it. Researchers will also look for signs that the drug helps control symptoms. The study is not yet recruiting and involves about 64 participants.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

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

Started

Mar 2026

Expected to finish

Jun 2028

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 75 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.

Inclusion Criteria: Part (A\&B): 1. Age of 18-55 years (HVs), 18-75 years (patients) 2. Body mass index between 18-30 kg/m², capped at 120 kg 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 Key Inclusion Criteria (Part B only) 1. Participants with physician-diagnosed CRSwNP before screening. 2. SNOT-22 total score ≥30 at screening and randomization. 3. Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months. 4. Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening. 5. For the participants have comorbid asthma, they had to be stable using their regular asthma treatment. Exclusion Criteria:Part (A\&B): 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 for (Part B only): 1. Any sinus/nasal surgery (including polypectomy) within 6 months before screening, History of \>2 prior sinus/nasal surgeries 2. Concurrent nasal conditions that may interfere with study assessments 3. Significant or unstable cardiovascular diseases 4. Recent clinically significant infection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    12 sites. 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

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • People's Hospital of Peking University

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Qingdao University Hospital

    RECRUITING

    Qingdao, Shandong, 266003, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • The Affiliated Yuhuangding Hospital of Qingdao University

    RECRUITING

    Yantai, Shandong, 264000, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325024, China

  • The Second Hospital of Chengdu City

    RECRUITING

    Chengdu, Sichuang, 610017, China

  • The Second Hospital of Shandong Province

    RECRUITING

    Jinan, Shandong, 250022, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510630, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

  • Zhejiang People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

  • Zibo Hospital of Shandong University

    RECRUITING

    Zibo, Shandong, 255036, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.