Recruiting
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients 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.
ClinicalTrials.gov IDNCT07436949
PhasePHASE1, PHASE2
Enrollment64
SponsorBambusa Therapeutics
Age18 Years
SexALL
Conditions studied
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
About this study
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.
Interventions
- Drug: BBT002 — BBT002 will be administered.
- Drug: Placebo — Placebo will be administered
Primary outcomes
- Number of participants with adverse events following single and multiple administration of BBT002 (Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration)
- Number of participants with change in vital sign measurements following dose administration. (Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration)
- Number of participants with change in physical examination following dose administration. (Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration)
- Number of participants with change in Laboratory assessments (Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration)
- Number of participants with change in 12-lead ECG readings (Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration)
Eligibility information
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
Study locations
- People's Hospital of Peking University, Beijing, Beijing Municipality 100044 China
- The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630 China
- Xiangya Hospital of Central South University, Changsha, Hunan 410008 China
- Jiangsu Province Hospital, Nanjing, Jiangsu 210029 China
- The Second Hospital of Shandong Province, Jinan, Shandong 250022 China
- Qingdao University Hospital, Qingdao, Shandong 266003 China
- The Affiliated Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000 China
- Zibo Hospital of Shandong University, Zibo, Shandong 255036 China
- Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality 200127 China
- The Second Hospital of Chengdu City, Chengdu, Sichuang 610017 China
Showing 10 of 12 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.