Chronic Obstructive Pulmonary DiseasePhase 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 Phase 1 study testing BBT002 in people with Chronic Obstructive Pulmonary Disease, run by Bambusa Therapeutics at 14 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BBT002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 8 May 2025to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
- Body mass index 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)
- Negative pregnancy tests for women of childbearing potential
- Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
- Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
- Adequate contraception use (for men and women of childbearing potential)
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- No clinically significant abnormalities or history of relevant diseases
- Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70
- 1. Participants with confirmed diagnosis of CRSwNP
Who cannot join
- Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
- Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
- History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal Electrocardiogram(ECG) findings
Show all 16Show fewer
- History of drug/alcohol abuse in the past 2 years
- History of severe allergic reactions or hypersensitivity
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry
- Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
- Sinonasal surgery (recent/extensiv)
- Consitions interfering with nasal assessments
- Excluded sinonasal/systemic diseases
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
Georgia4 sites, 4 recruiting
- Recruiting
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0198
Dr. Sopiko Kruashvili, +995598530083, Sophiekruashvili@gmail.com
Dr. Sopiko Kruashvili
- Recruiting
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, 0198
Dr. Elene Khurtsidze, +995574747574, ekhurtsidze@gh.ge
Elene Khurtsidze
- Recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0198
Dr. Shorena Khazaradze, shorenakhazaradze01@gmail.com
Dr. Shorena Khazaradze
- Recruiting
Ltd Aversi Clinic
Tbilisi, 0198
Dr. David Tchkonia, +995577785575, David.tchkonia@gmail.com
David Tchkonia
United States3 sites, 3 recruiting
- Recruiting
Equity Medical Bowling Green
Bowling Green, Kentucky, 42104
Dr. James Allred, 844-378-9633, Jallred@equity-med.com
Dr. James Allred
- Recruiting
Equity Medical LLC
New York, New York, 10023
Dr. Monalyn Zousias, 844-378-9633, Mzouzias@equity-med.com
Dr. Monalyn Zousias
- Not yet recruiting
Equity Medical - Owensboro
Owensboro, Kentucky, 42303
Dr. David Johnsonn, 270-426-9184 ext. 457, djohnson@equity-med.com
Dr. David Johnsonn
New Zealand3 sites, 3 recruiting
- Recruiting
Momentum Clinical Research
Pukekohe, 2120
Dr Michelle Baker, +640508919919, Michelle.baker@momentumclinicalresearch.co.nz
Dr Michelle Baker
- Not yet recruiting
Momentum Clinical Research Hamilton
Rotorua, Hamilton, 3010
Dr Victoria Siriett, 0273415595, Victoria@clinicaltrialswaikato.co.nz
Dr Victoria Siriett
- Recruiting
Momentum Clinical Research
Wellington, 6021
Dr Dean Quinn, +6448010002, dean@p3research.co.nz
Dr Dean Quinn
Australia2 sites, 2 recruiting
- Recruiting
Momentum Clinical Research
Brisbane, 4068
Dr Xin Yi (Ellie) Ngoh, 0732785255, Ellie.Ngoh@momentumclinicalresearch.com.au
Dr Xin Yi (Ellie) Ngoh
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
Lara Hatchuel, Dr
Dr. Lara Hatchuel
Poland2 sites, 2 recruiting
- Not yet recruiting
Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz
Gdansk, 80-214
Iwona Damps-Konstanska, +48 535575210, katarzyna.swietnicka@gmail.com
Iwona Damps-Konstanska
- Not yet recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, 31-011
Katarzyna Gajda, 48690000367, katarzyna.gajda@dobrylekarz.com.pl
Katarzyna Gajda
About this study
Official title: 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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BBT002, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT002Drug
BBT002 will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A: BBT002 | Experimental | A single dose of BBT002 will be administered in healthy volunteers Receives: Drug: BBT002 |
| Part B: BBT002 | Experimental | Multiple doses of BBT002 will be administered in healthy volunteers. Receives: Drug: BBT002 |
| Part C: BBT002 | Experimental | Multiple doses of BBT002 will be administered in patients with COPD Receives: Drug: BBT002 |
| Part A: Placebo | Placebo comparator | A single dose of Placebo will be administered in healthy volunteers. Receives: Drug: Placebo |
| Part B: Placebo | Placebo comparator | Multiple doses of Placebo will be administered in healthy volunteers. Receives: Drug: Placebo |
| Part C: Placebo | Placebo comparator | Multiple doses of Placebo will be administered in patients with COPD. Receives: Drug: Placebo |
| Part D: Placebo | Placebo comparator | Multiple doses of Placebo will be administered in patients with CRSwNP. Receives: Drug: Placebo |
| Part E: Placebo | Placebo comparator | Single dose of Placebo will be administered in healthy volunteers. Receives: Drug: Placebo |
| Part F: Placebo | Placebo comparator | Multiple doses of Placebo will be administered in patients with COPD. Receives: Drug: Placebo |
| Part G: Placebo | Placebo comparator | Multiple doses of Placebo will be administered in patients with CRSwNP. Receives: Drug: Placebo |
| Part D: BBT002 | Experimental | Multiple doses of BBT002 will be administered in patients with CRSwNP. Receives: Drug: BBT002 |
| Part E: BBT002 | Experimental | Single dose of BBT002 will be administered in healthy volunteers. Receives: Drug: BBT002 |
| Part F: BBT002 | Experimental | Multiple doses of BBT002 will be administered in patients with COPD. Receives: Drug: BBT002 |
| Part G: BBT002 | Experimental | Multiple doses of BBT002 will be administered in patients with CRSwNP. Receives: Drug: BBT002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of participants with change in Laboratory assessments
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Measured: 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
Number of participants with change in vital sign measurements following dose administration.
Blood pressure and heart rate will be assessed.
Measured: 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
Number of participants with change in physical examination following dose administration.
Physical examination will be assessed.
Measured: 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
Number of participants with change in 12-lead ECG readings
12-lead ECG will be assessed.
Measured: 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 (7)
PK parameters- maximum observed concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time of maximum observed Concentration (Tmax)
Serum PK Tmax will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)
Total clearance of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2).
Elimination half-life of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
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
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start8 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambusa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Ji, Study director, Bambusa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944925
- Sponsor's protocol ID
- BBT002-001
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06944925
- Acronym / sponsor ID
- BBT002-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Bambusa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part A: BBT002 | Experimental | Drug: BBT002A single dose of BBT002 will be administered in healthy volunteers |
| Part B: BBT002 | Experimental | Drug: BBT002Multiple doses of BBT002 will be administered in healthy volunteers. |
| Part C: BBT002 | Experimental | Drug: BBT002Multiple doses of BBT002 will be administered in patients with COPD |
| Part A: Placebo | Placebo comparator | Drug: PlaceboA single dose of Placebo will be administered in healthy volunteers. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in healthy volunteers. |
| Part C: Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in patients with COPD. |
| Part D: Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in patients with CRSwNP. |
| Part E: Placebo | Placebo comparator | Drug: PlaceboSingle dose of Placebo will be administered in healthy volunteers. |
| Part F: Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in patients with COPD. |
| Part G: Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in patients with CRSwNP. |
| Part D: BBT002 | Experimental | Drug: BBT002Multiple doses of BBT002 will be administered in patients with CRSwNP. |
| Part E: BBT002 | Experimental | Drug: BBT002Single dose of BBT002 will be administered in healthy volunteers. |
| Part F: BBT002 | Experimental | Drug: BBT002Multiple doses of BBT002 will be administered in patients with COPD. |
| Part G: BBT002 | Experimental | Drug: BBT002Multiple doses of BBT002 will be administered in patients with CRSwNP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
- Body mass index 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)
- Negative pregnancy tests for women of childbearing potential
- Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
- Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
Key exclusion criteria (16 listed)
- Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
- Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
- History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBT002BBT002 will be administered. | Drug | Part A: BBT002, Part B: BBT002, Part C: BBT002, Part D: BBT002, Part E: BBT002, Part F: BBT002, Part G: BBT002 |
| PlaceboPlacebo will be administered. | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo, Part D: Placebo, Part E: Placebo, Part F: Placebo, Part G: Placebo |
Primary outcome
Number of participants with adverse events following single and multiple administration of BBT002
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
Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.
Number of participants with change in Laboratory assessments
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
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Number of participants with change in vital sign measurements following dose administration.
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
Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following dose administration.
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
Physical examination will be assessed.
Number of participants with change in 12-lead ECG readings
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
12-lead ECG will be assessed.
7 secondary outcomes
PK parameters- maximum observed concentration (Cmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time of maximum observed Concentration (Tmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Area under the curve (AUC)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2).
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy Ji study director
Bambusa Therapeutics, Inc.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBT002 in people with Chronic Obstructive Pulmonary Disease, run by Bambusa Therapeutics at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Georgia, United States, New Zealand, Australia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Ji (+86 18001322760, Tracy.Ji@bambusatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events following single and multiple administration of BBT002 (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.