Study of BBT002 Safety and Effects in Healthy Adults and Adults with COPD Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Trial

What this Trial Is About

Researchers are evaluating BBT002, a drug being studied to assess its safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in both healthy volunteers and people with Chronic Obstructive Pulmonary Disease COPD. The study is a randomized, double-blind, placebo-controlled trial conducted in two parts, including single and multiple ascending dose evaluations. This research aims to understand how BBT002 behaves in the body and its effects over time in these groups. The trial has two parts Part A involves administering a single dose of BBT002 or placebo to healthy volunteers in sequential dose groups. Part B involves giving two repeated doses of BBT002 or placebo to participants with COPD. Each participant will receive either the study drug or placebo depending on their group assignment. The study monitors responses to both single and multiple doses, with treatments given under close medical supervision. Participants will undergo assessments including monitoring for adverse events, laboratory tests, vital sign checks, physical exams, and electrocardiograms ECGs up to 141 days after dosing in healthy volunteers and up to 169 days in COPD patients. Pharmacokinetic measurements such as drug concentration and clearance will be collected at specified times. The study also tracks immune responses to the drug. Overall participation involves multiple visits and evaluations over several months to ensure comprehensive safety and activity data.

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)