A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
Recruiting · NCT07436949 · Interventional (participants receive a specific treatment) · Lead sponsor: Bambusa Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
BBT002Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Part (A\&B):
- 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
- Key Inclusion Criteria (Part B only)
- 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 criteria
- Part (A\&B):
- 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
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal Electrocardiogram(ECG) findings
- History of drug/alcohol abuse in the past 2 years
- History of severe allergic reactions or hypersensitivity
- Key Exclusion Criteria for (Part B only):
- 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
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
Where it is running
12 locations listed.
- People's Hospital of Peking University - Beijing, Beijing Municipality, China
- The Third Affiliated Hospital of Sun Yat-sen University - Guangzhou, Guangdong, China
- Xiangya Hospital of Central South University - Changsha, Hunan, China
- Jiangsu Province Hospital - Nanjing, Jiangsu, China
- The Second Hospital of Shandong Province - Jinan, Shandong, China
- Qingdao University Hospital - Qingdao, Shandong, China
- The Affiliated Yuhuangding Hospital of Qingdao University - Yantai, Shandong, China
- Zibo Hospital of Shandong University - Zibo, Shandong, China
- Renji Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China
- The Second Hospital of Chengdu City - Chengdu, Sichuang, China
- Zhejiang People's Hospital - Hangzhou, Zhejiang, China
- The Second Affiliated Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China