BBT002 in healthy volunteers and people with chronic rhinosinusitis with nasal polyps
Tests BBT002 in healthy adults and adults with nasal polyps, with or without asthma.
Plain-language title generated from the registry record
Registry title: A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
Key facts
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Hangzhou, Jinan, Nanjing, Qingdao, Shanghai, Wenzhou, Yantai, and Zibo, ChinaSee the 12 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07436949, who can take part
Where in China
- People's Hospital of Peking UniversityBeijing, ChinaTaking people
- Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- The Second Hospital of Chengdu CityChengdu, ChinaTaking people
- The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, ChinaTaking people
- Zhejiang People's HospitalHangzhou, ChinaTaking people
- The Second Hospital of Shandong ProvinceJinan, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- Qingdao University HospitalQingdao, ChinaTaking people
- Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
- The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- The Affiliated Yuhuangding Hospital of Qingdao UniversityYantai, ChinaTaking people
- Zibo Hospital of Shandong UniversityZibo, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bambusa Therapeutics
- Trial code
- NCT07436949
- Record updated
- 22 July 2026
- Original description
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.Read full original descriptionShow less
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 Comorbid Asthma
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.
Inclusion: Age of 18-55 years (HVs), 18-75 years (patients); Body mass index between 18-30 kg/m², capped at 120 kg; Negative pregnancy tests for women of childbearing potential; Willingness to refrain from alcohol consumption for 24 hours prior to each study visit; Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex smokers; Participants with physician-diagnosed CRSwNP before screening; SNOT-22 total score ≥30 at screening and randomization; Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months; Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening; For the participants have comorbid asthma, they had to be stable using their regular asthma treatment.
Exclusion: Positive drug/alcohol tests or abnormal vital signs at screening or Day -1; Any sinus/nasal surgery (including polypectomy) within 6 months before screening, History of >2 prior sinus/nasal surgeries; Concurrent nasal conditions that may interfere with study assessments; Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV); Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections; History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders; History of drug/alcohol abuse in the past 2 years; History of severe allergic reactions or hypersensitivity; Significant or unstable cardiovascular diseases; Recent clinically significant infection; Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function; Abnormal Electrocardiogram(ECG) findings.