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.
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
Sequential
BBT002
DrugBBT002 will be administered.
Placebo
DrugPlacebo will be administered
Number of participants with adverse events following single and multiple administration of BBT002
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.
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.
Physical examination will be assessed.
Number of participants with change in Laboratory assessments
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
PK parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
PK parameters- maximum observed concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
PK parameters- Time for maximum observed Concentration (Tmax)
Serum PK Tmax will be analyzed for all subjects
PK parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
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