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A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllBambusa Therapeutics
NCT07436949 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a randomized, double-Blind, placebo-controlled, Single and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma.

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📋 Eligibility rules (as published)
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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What it tests

  • BBT002
  • Placebo
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Where

12 sites
People's Hospital of Peking University
Beijing, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Xiangya Hospital of Central South University
Changsha, China
Jiangsu Province Hospital
Nanjing, China
The Second Hospital of Shandong Province
Jinan, China
Qingdao University Hospital
Qingdao, China
The Affiliated Yuhuangding Hospital of Qingdao University
Yantai, China
Zibo Hospital of Shandong University
Zibo, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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