RecruitingPhase 1NCT06944925

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

A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in HVs and COPD Patients


Sponsor

Bambusa Therapeutics

Enrollment

98 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new inhaled medication called BBT002 in healthy volunteers and in people with chronic obstructive pulmonary disease (COPD), a lung condition that makes it hard to breathe. The goal is to assess how safe and effective it is. **You may be eligible if...** - You are between 18–65 years old (healthy volunteers) or 35–75 years old (COPD patients) - Your body weight and BMI fall within the study's acceptable range - You are a non-smoker, light smoker (5 or fewer cigarettes per day), or ex-smoker - For the COPD part: you have a documented COPD diagnosis and your lung function meets the study criteria - You are using adequate contraception if applicable **You may NOT be eligible if...** - You have significant heart, liver, kidney, or other organ problems - You are pregnant or breastfeeding - You have recently used other medications that could interfere with the study drug - Your COPD is currently very poorly controlled or you've had a recent flare-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBBT002

BBT002 will be administered.

DRUGPlacebo

Placebo will be administered.


Locations(1)

Linear Clinical Research

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06944925


Related Trials