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New treatment option for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Official title A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
ClinicalTrials.gov ID: NCT07436949
What this study is testing
What is BBT002?
BBT002 is an investigational medicine, being studied as a potential treatment for chronic rhinosinusitis with nasal polyps (crswnp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 (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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Yantai, Shandong, China
- Zibo, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuang, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Jinan, Shandong, China; Qingdao, Shandong, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.