Evaluation of BBT002 Safety and Effects in Healthy Adults and Patients with COPD or Chronic Rhinosinusitis with Nasal Polyps

What this Trial Is About

Researchers are conducting a randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, immunogenicity, and exploratory clinical activity of BBT002. This study includes healthy adults and patients with chronic obstructive pulmonary disease COPD or chronic rhinosinusitis with nasal polyps CRSwNP. BBT002 is being developed as a potential treatment for these conditions and is administered via intravenous or subcutaneous injection. The study involves several parts where participants receive either single or multiple doses of BBT002 or placebo. Healthy volunteers receive both single and multiple doses, while patients with COPD or CRSwNP receive multiple doses. The study is designed with a sequential model and includes multiple treatment arms comparing BBT002 to placebo across these groups. Participants will undergo safety and lab assessments including monitoring for adverse events, vital signs, physical examinations, ECG readings, and laboratory tests for up to 141 to 169 days after the first dose depending on the study part. Pharmacokinetic parameters and immunogenicity through anti-drug antibody development will be evaluated at specified timepoints. The total duration includes follow-up periods to monitor safety and treatment effects.

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)