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) and Comorbid Asthma.
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
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