RecruitingPhase 1NCT07288554

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

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 Participants With Chronic Obstructive Pulmonary Disease (COPD)


Sponsor

Bambusa Therapeutics

Enrollment

68 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is 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 Participants with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new inhaled drug called BBT002 in healthy volunteers (Part A) and in people with moderate COPD — a chronic lung disease that makes breathing difficult (Part B) — to evaluate its safety and how it works in the body. **You may be eligible if...** - You are between 18 and 65 years old (healthy volunteers) or 35 and 75 years old (COPD patients) - Your BMI is between 18 and 32 kg/m² and you weigh under 120 kg - For COPD patients: you have a confirmed COPD diagnosis with moderate airflow limitation on breathing tests (FEV1 50–80% predicted) - You are a non-smoker, light smoker (up to 5 cigarettes/day), or ex-smoker - You are using adequate contraception if of childbearing potential **You may NOT be eligible if...** - You have HIV, hepatitis B or C - Your lung function is below 50% or above 80% predicted (for COPD group) - You have significant other illnesses - You have a positive pregnancy test 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(11)

The Second Hospital of Anhui Medical Univesity

Hefei, Anhui, China

The third affiliated hosptial of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

The First People's Hospital of Xinxiang City

Xinxiang, Henan, China

Yichang Central People's Hospital

Yichang, Hubei, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Chengdu fifth People's Hospital

Chengdu, Sichuang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07288554


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