BBT002 in healthy adults and in people with chronic rhinosinusitis with nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, randomized, double-blind, placebo-controlled study of BBT002 in healthy volunteers and in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Part A evaluates single-dose safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics in healthy volunteers across ascending dose groups. Part B assesses five repeated doses in CRSwNP patients to explore safety and potential clinical activity. The study includes adults aged 18-55 among healthy volunteers and 18-75 among patients, with specific criteria for CRSwNP and asthma comorbidity, and excludes certain infections and high-risk conditions. Primary comparisons are BBT002 versus placebo, with outcomes spanning safety, PK/PD, and immunogenicity, plus exploratory clinical activity signals in CRSwNP.

Why it matters

Who can join: the full rules

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

Where it's running

• People's Hospital of Peking University
  Beijing, Beijing Municipality, China Recruiting
• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting
• The Second Hospital of Shandong Province
  Jinan, Shandong, China Recruiting
• Qingdao University Hospital
  Qingdao, Shandong, China Recruiting

Study contacts

• Study coordinator: Tracy Ji, Senior study Director
• Email: Tracy.Ji@bambusatx.com
• Phone: +86 18001322760

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

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• Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes

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• Real-world use of tezepelumab for chronic rhinosinusitis with nasal polyps in Russia

  This study will see how tezepelumab works in adults in Russia who have chronic rhinosinusitis with nasal polyps, with or without asthma.

  Recruiting at 10 sites AstraZeneca · Kazan' and 9 other locations · NCT07399665

• Joint pulmonologist and ENT consult for asthma with nasal polyps care

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• Real-time detection of eosinophilic nasal polyps using high-sensitivity spectroscopy

  This will test a non-invasive light-based device that shines a safe light into the nose to quickly find eosinophilic nasal polyps in adults with chronic rhinosinusitis with nasal polyps.

  Recruiting The Affiliated Hospital of Qingdao University · Qingdao, Shandong · NCT07125586

• Understanding how inflammation affects smell in chronic rhinosinusitis

  This study is testing whether a new treatment for inflammation can help improve the sense of smell in people with chronic rhinosinusitis and nasal polyps.

  Recruiting Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Brussels · NCT06776042

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.