68 Participants NeededMy employer runs this trial

BBT002 for COPD

Recruiting at 2 trial locations
TJ
Overseen ByTracy Ji, Study Director
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bambusa Therapeutics

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BBT002, a potential drug for Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes breathing difficult. Researchers aim to determine the safety of BBT002 and its effects on the body compared to a placebo, which contains no active drug. The trial consists of two main parts: one for healthy volunteers and another for those with COPD. Each group receives either a single or multiple doses of the treatment or placebo. Individuals with a history of COPD and frequent breathing difficulties might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BBT002 is likely to be safe for humans?

Earlier research tested BBT002 on both healthy individuals and those with COPD, a lung condition. The studies assessed its safety and tolerability. Initial results indicate that BBT002 was generally well-tolerated, with most participants experiencing no serious side effects. The trials included up to 98 participants aged 35 to 75. These trials found no major safety issues, which is encouraging for prospective participants in future studies. However, as this is an early-phase trial, researchers are still learning about its full safety profile.12345

Why do researchers think this study treatment might be promising for COPD?

Researchers are excited about BBT002 because it introduces a novel approach to treating COPD. Unlike standard treatments like bronchodilators and inhaled corticosteroids, BBT002 is designed to work by a different mechanism that has the potential to address inflammation more effectively. This new method could lead to better symptom control and improved lung function, offering hope for patients who don't fully benefit from current therapies. Additionally, BBT002's dosing strategy is being explored to enhance patient convenience and adherence, which could make managing COPD easier for those affected.

What evidence suggests that BBT002 might be an effective treatment for COPD?

Research has shown that BBT002 could help treat COPD. In studies with mice, BBT002 performed as well as or better than Dupixent in reducing lung inflammation. Early results from human studies, presented at the American Thoracic Society conference, were positive and suggest BBT002 might be beneficial. In this trial, participants will receive either a single or multiple ascending doses of BBT002, or a placebo. This treatment targets two key areas involved in COPD, potentially reducing symptoms and improving lung function. These findings indicate that BBT002 might be a promising option for managing COPD symptoms in the future.12356

Are You a Good Fit for This Trial?

This trial is for adults with COPD diagnosed at least a year ago, who have smoked heavily and used daily inhalers for the past 3 months. People can't join if they've had recent lung infections or flare-ups, other serious lung diseases, need lots of oxygen or breathing machines, or recently used steroid pills/shots.

Inclusion Criteria

Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) by a doctor for at least 1 year?
Have you smoked cigarettes a pack or more per day for multiple years?
Have you used a daily inhaler to control your COPD for the past 3 months?

Exclusion Criteria

In the last month, have you had a COPD flare-up, pneumonia, or a chest (lung) infection?
Besides COPD, has a doctor diagnosed you with another lung disease (such as lung cancer, pulmonary fibrosis, or bronchiectasis)?
Do you receive supplemented oxygen for more than 12 hours a day, or a home breathing machine (BiPAP)?
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) in Healthy Volunteers

A single dose of BBT002 or placebo is administered to healthy volunteers in sequential ascending dose cohorts

Up to 141 days
Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD) in COPD Patients

Two doses of BBT002 or placebo are administered to patients with COPD

Up to 169 days
Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 169 days post first dose administration

What Are the Treatments Tested in This Trial?

Interventions

  • BBT002

Trial Overview

The study tests different doses of a new drug called BBT002 compared to a placebo (inactive treatment) in both healthy volunteers and people with COPD. Participants are randomly assigned to groups and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B Multiple Ascending Dose BBT002Experimental Treatment1 Intervention
Group II: Part A Single Ascending Dose BBT002Experimental Treatment1 Intervention
Group III: Part B Multiple Ascending Dose PlaceboPlacebo Group1 Intervention
Group IV: Part A Single Ascending Dose PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bambusa Therapeutics

Lead Sponsor

Trials
1
Recruited
100+

Citations

A Study of BBT002 in Healthy Volunteers (HVs) and ...

This study is a randomized, double-Blind, placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, ...

BBT002 / Bambusa Therapeutics

Bambusa Therapeutics Presents Positive Preliminary Phase 1 BBT002 Data at American Thoracic Society 2026 (ATS 2026) International Conference…

Bambusa Therapeutics Announces First Patient Dosed in ...

The Phase Ib study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BBT002 in COPD as well as other type 2 ...

BBT002 Phase Ib Study in COPD Patients

Real-world data from the Omicron era A multicenter retrospective study compares the efficacy and safety of sotrovimab versus oral antivirals for ...

Bambusa Therapeutics Announces First Patient Dosed in ...

The Phase Ib study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BBT002 in COPD as well as other type 2 ...

A Study of BBT002 in Healthy Volunteers (HVs) and ...

This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, ...