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New COPD drug BBT002 enters first human safety trials

NCT ID NCT07288554

Symptom relief Sponsor: Bambusa Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called BBT002 in healthy people and those with COPD to see if it is safe and tolerable. Researchers will also look for early signs that it might ease breathing problems. About 68 participants will receive either the drug or a placebo, with doses increased gradually.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:( A\&B) 1. Age of 18-65 years (HVs), 35-75 years (patients) 2. Body mass index between 18-32 kg/m², capped at 120 kg 3. Negative pregnancy tests for women of childbearing potential 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers 6. Adequate contraception use (for men and women of childbearing potential) 7. No clinically significant abnormalities or history of relevant diseases Key Inclusion Criteria (Part B only) 1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70 2. FEV1 ≥ 30% and FEV1\<80% predicted at screening. Exclusion Criteria:( part A \& B) 1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV) 2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections 3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders 4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function 5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1 6. Abnormal Electrocardiogram(ECG) findings 7. History of drug/alcohol abuse in the past 2 years 8. History of severe allergic reactions or hypersensitivity Key Exclusion Criteria for (Part B only) 1. Current diagnosis of other significant pulmonary disease 2. Significant or unstable cardiovascular diseases 3. Recent clinically significant infection 4. Inability to perform spirometry

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease (COPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chengdu fifth People's Hospital

    RECRUITING

    Chengdu, Sichuang, 611130, China

  • Jiangmen Central Hospital

    RECRUITING

    Jiangmen, Guangdong, 529000, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Qingyuan People's Hospital

    RECRUITING

    Qingyuan, Guangdong, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, 221002, China

  • The First Affiliated Hospital of Guangdong Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • The First People's Hospital of Xinxiang City

    RECRUITING

    Xinxiang, Henan, 453000, China

  • The Second Hospital of Anhui Medical Univesity

    RECRUITING

    Hefei, Anhui, 230601, China

  • The third affiliated hosptial of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 020-81292183, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443000, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.