NCT07436949RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 22 Feb 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Bambusa Therapeutics
- Diseases
- Asthma
- NCT number
- NCT07436949
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 64
- From 2 Mar 2026 to the primary completion date, 31 Dec 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
Other
- Abnormal Electrocardiogram(ECG) findings
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| People's Hospital of Peking University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Second Hospital of Chengdu City Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Hospital of Shandong Province Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Qingdao University Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| The Affiliated Yuhuangding Hospital of Qingdao University Coordinator of this site? Confirm its status | Yantai | China | Recruiting |
| Zibo Hospital of Shandong University Coordinator of this site? Confirm its status | Zibo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.