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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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 Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
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 Changes in vital sign measurements, physical examination, clinical laboratory test findings, and 12-lead results.
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 Physical examination will be assessed.
Number of participants with change in Laboratory assessments — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
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 12-lead ECG will be assessed.
Trial sites (12)
Facility
City
Region
Status
People's Hospital of Peking University
Beijing
Beijing Municipality
Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The Second Hospital of Shandong Province
Jinan
Shandong
Recruiting
Qingdao University Hospital
Qingdao
Shandong
Recruiting
The Affiliated Yuhuangding Hospital of Qingdao University
Yantai
Shandong
Recruiting
Zibo Hospital of Shandong University
Zibo
Shandong
Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
The Second Hospital of Chengdu City
Chengdu
Sichuang
Recruiting
Zhejiang People's Hospital
Hangzhou
Zhejiang
Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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