Clinical Trials in China / NCT07436949
Recruiting
Phase 1/2
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
NCT07436949 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Investigational drug(s) / intervention(s)
BBT002 →Placebo
BBT002: BBT002 will be administered.
Placebo: Placebo will be administered
Study summary
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
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 | Wenzhou | Zhejiang | Recruiting |
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Official registry record
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.
View NCT07436949 on ClinicalTrials.gov ↗ ← All trials in China