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
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).
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.
Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)
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
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)
Key Exclusion Criteria (Part C and F only)
Key Exclusion Criteria (Parts D and G)
A single dose of BBT002 will be administered in healthy volunteers
Drug: BBT002
Multiple doses of BBT002 will be administered in healthy volunteers.
Drug: BBT002
Multiple doses of BBT002 will be administered in patients with COPD
Drug: BBT002
A single dose of Placebo will be administered in healthy volunteers.
Drug: Placebo
Multiple doses of Placebo will be administered in healthy volunteers.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with COPD.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with CRSwNP.
Drug: Placebo
Single dose of Placebo will be administered in healthy volunteers.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with COPD.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with CRSwNP.
Drug: Placebo
Multiple doses of BBT002 will be administered in patients with CRSwNP.
Drug: BBT002
Single dose of BBT002 will be administered in healthy volunteers.
Drug: BBT002
Multiple doses of BBT002 will be administered in patients with COPD.
Drug: BBT002
Multiple doses of BBT002 will be administered in patients with CRSwNP.
Drug: BBT002
BBT002 will be administered.
Placebo will be administered.
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
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
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
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
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
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
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
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
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
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
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
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
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Pulmonary Disease, Chronic Obstructive→
Bambusa Therapeutics