A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

Korábbi kezelés

• 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

Más betegség

• 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

Laborértékek

• Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function

Egyéb

• Abnormal Electrocardiogram(ECG) findings

• 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.