RecruitingPhase 1NCT06944925

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)

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 Patients With COPD or CRSwNP


Sponsor

Bambusa Therapeutics

Enrollment

286 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 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.

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Interventions

DRUGBBT002

BBT002 will be administered.

DRUGPlacebo

Placebo will be administered.


Locations(14)

Equity Medical Bowling Green

Bowling Green, Kentucky, United States

Equity Medical - Owensboro

Owensboro, Kentucky, United States

Equity Medical LLC

New York, New York, United States

Linear Clinical Research

Perth, Western Australia, Australia

Momentum Clinical Research

Brisbane, Australia

Aleksandre Aladashvili Clinic LLC

Tbilisi, Georgia

Geo Hospitals Tbilisi Multiprofile Medical Center

Tbilisi, Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

Ltd Aversi Clinic

Tbilisi, Georgia

Momentum Clinical Research Hamilton

Rotorua, Hamilton, New Zealand

Momentum Clinical Research

Pukekohe, New Zealand

Momentum Clinical Research

Wellington, New Zealand

Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz

Gdansk, Poland

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Krakow, Poland

View Full Details on ClinicalTrials.gov

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NCT06944925


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