NCT06944925 · Bambusa Therapeutics
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)
What this study is about
randomly assigned 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).
View original scientific description
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).
Interventions
DRUG
BBT002
BBT002 will be administered.
DRUG
Placebo
Placebo will be administered.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Parts A, B, C, D, E, F, and G)
- 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)
- 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 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)
- 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
- History of drug/alcohol abuse in the past 2 years
- History of severe allergic reactions or hypersensitivity Key Exclusion Criteria (Part C and F only)
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry Key Exclusion Criteria (Parts D and G)
- Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
- Sinonasal surgery (recent/extensiv)
- Consitions interfering with nasal assessments
- Excluded sinonasal/systemic diseases
Where
- Bowling Green, Kentucky
- Owensboro, Kentucky
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations