ClinicalTrials.gg
RecruitingNCT06944925Updated Jul 1, 2026

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 Phase 1 interventional study of BBT002 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Bambusa Therapeutics. Recruiting at 14 sites in 5 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Bambusa Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Pulmonary Disease, Chronic Obstructive with a site in Georgia — 4 open to participants now, 6 under way, 1 of them phase 3. Pulmonary Disease, Chronic Obstructive · Georgia.

Planned enrollment
10th of 13
286 · median 669
Started
2025
with 3 others
Phase 1
2 of 13
2 open now
Registered
10th of 13
by date
Lead sponsor
1 of 13
Bambusa Therapeutics

Among the 13 studies in Pulmonary Disease, Chronic Obstructive with a site in Georgia, this one is the 10th largest by planned enrollment, is one of 4 that started in 2025, is one of 2 in phase 1, and was the 10th registered.

Pulmonary Disease, Chronic Obstructive

5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

4 of the 13 studies in Pulmonary Disease, Chronic Obstructive with a site in Georgia are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Georgia have not opened yet or have stopped. Only those recruiting at a site in Georgia →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Pulmonary Disease, Chronic Obstructive with a site in Georgia, or all of them as a file.
02

Study 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).

Read the detailed description

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)

  1. Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
  2. between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)
  3. Negative pregnancy tests for women of
  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 use (for men and women of childbearing potential)
  7. No abnormalities or history of relevant diseases

Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator /Forced Vital Capacity less than 0.70

Key Inclusion Criteria (Parts D and G)

1. Participants with confirmed diagnosis of CRSwNP

Key Exclusion Criteria for (Parts A, B, C, D, E, F, and G)

  1. Positive viral serology for (HlV), virus (HCV), or (HBV)
  2. Immunodeficiencies, 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 (ECG) findings
  7. History of drug/alcohol abuse in the past 2 years
  8. History of severe allergic reactions or

Key Exclusion Criteria (Part C and F 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

Key Exclusion Criteria (Parts D and G)

  1. refractoriness: to systemic corticosteriods for CRSwNP
  2. Sinonasal surgery (recent/extensiv)
  3. Consitions interfering with nasal assessments
  4. Excluded sinonasal/systemic diseases
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
286 participants (estimated)

Study arms

  • Experimental
    Part A: BBT002

    A single dose of BBT002 will be administered in healthy volunteers

    Drug: BBT002

  • Experimental
    Part B: BBT002

    Multiple doses of BBT002 will be administered in healthy volunteers.

    Drug: BBT002

  • Experimental
    Part C: BBT002

    Multiple doses of BBT002 will be administered in patients with COPD

    Drug: BBT002

  • Placebo comparator
    Part A: Placebo

    A single dose of Placebo will be administered in healthy volunteers.

    Drug: Placebo

  • Placebo comparator
    Part B: Placebo

    Multiple doses of Placebo will be administered in healthy volunteers.

    Drug: Placebo

  • Placebo comparator
    Part C: Placebo

    Multiple doses of Placebo will be administered in patients with COPD.

    Drug: Placebo

  • Placebo comparator
    Part D: Placebo

    Multiple doses of Placebo will be administered in patients with CRSwNP.

    Drug: Placebo

  • Placebo comparator
    Part E: Placebo

    Single dose of Placebo will be administered in healthy volunteers.

    Drug: Placebo

  • Placebo comparator
    Part F: Placebo

    Multiple doses of Placebo will be administered in patients with COPD.

    Drug: Placebo

  • Placebo comparator
    Part G: Placebo

    Multiple doses of Placebo will be administered in patients with CRSwNP.

    Drug: Placebo

  • Experimental
    Part D: BBT002

    Multiple doses of BBT002 will be administered in patients with CRSwNP.

    Drug: BBT002

  • Experimental
    Part E: BBT002

    Single dose of BBT002 will be administered in healthy volunteers.

    Drug: BBT002

  • Experimental
    Part F: BBT002

    Multiple doses of BBT002 will be administered in patients with COPD.

    Drug: BBT002

  • Experimental
    Part G: BBT002

    Multiple doses of BBT002 will be administered in patients with CRSwNP.

    Drug: BBT002

Interventions

  • DrugBBT002

    BBT002 will be administered.

  • DrugPlacebo

    Placebo will be administered.

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events following single and multiple administration of BBT002

    Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.

    Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

  2. Number of participants with change in Laboratory assessments

    Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

    Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

  3. Number of participants with change in vital sign measurements following dose administration.

    Blood pressure and heart rate will be assessed.

    Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

  4. Number of participants with change in physical examination following dose administration.

    Physical examination will be assessed.

    Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

  5. Number of participants with change in 12-lead ECG readings

    12-lead ECG will be assessed.

    Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

Secondary outcomes

  1. PK parameters- maximum observed concentration (Cmax)

    Maximum observed concentration of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  2. PK parameters- Time of maximum observed Concentration (Tmax)

    Serum PK Tmax will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  3. PK parameters- Area under the curve (AUC)

    Area under the curve of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  4. PK parameters- Volume of distribution (Vz)

    Volume of distribution of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  5. PK parameters- Total clearance (CL)

    Total clearance of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  6. PK parameters- - Elimination Half-life (t1/2).

    Elimination half-life of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  7. The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).

    Serum Anti-Drug Antibodies will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

07

Study locations

10 of 14 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.

Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's planned 20 months is above that.

Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2025
First posted
Apr 25, 2025
StartActual
May 8, 2025
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06944925
Lead sponsor
Bambusa Therapeutics
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
May 8, 2025
Primary completion
Jan 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

Tracy Ji
Contact
Tracy.Ji@bambusatx.com
+86 18001322760
Tracy Ji
study director · Bambusa Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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