About this trial
Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligibility criteria
Qualifiers
Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)
Negative pregnancy tests for women of childbearing potential
Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
Disqualifiers
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
Trial design
Treatments tested in this trial
- BBT002
- Placebo
Treatment groups
14
Treatment groupsSee each treatment group below.