New drug BBT002 aims to ease sinus and asthma symptoms
NCT ID NCT07436949
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 210029, China
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People's Hospital of Peking University
RECRUITINGBeijing, Beijing Municipality, 100044, China
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Qingdao University Hospital
RECRUITINGQingdao, Shandong, 266003, China
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200127, China
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The Affiliated Yuhuangding Hospital of Qingdao University
RECRUITINGYantai, Shandong, 264000, China
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The Second Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325024, China
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The Second Hospital of Chengdu City
RECRUITINGChengdu, Sichuang, 610017, China
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The Second Hospital of Shandong Province
RECRUITINGJinan, Shandong, 250022, China
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The Third Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510630, China
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Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410008, China
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Zhejiang People's Hospital
RECRUITINGHangzhou, Zhejiang, 310014, China
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Zibo Hospital of Shandong University
RECRUITINGZibo, Shandong, 255036, China
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Other studies related to the condition(s) this trial covers.
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- Can a simple breath test cut asthma Flare-Ups?
- Breathing tests face off: can extra lung measurements improve asthma diagnosis?
- The carbon label on your inhaler: can it sway a Doctor's choice?
- Six biologics put to the test in Real-World asthma and COPD care
- Can a digital program help teens with chronic illnesses move to adult care?