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)
Bambusa Therapeutics · NCT06944925
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 286
- US sites recruiting
- 2
- Study start
- May 8, 2025
- Record last updated
- July 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: BBT002; Placebo
Conditions: Chronic Obstructive Pulmonary Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key 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)
- 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
Recruiting US locations
Equity Medical Bowling Green
Bowling Green, KY 42104
Site contact: Dr. James Allred · 844-378-9633 · Jallred@equity-med.com
Equity Medical LLC
New York, NY 10023
Site contact: Dr. Monalyn Zousias · 844-378-9633 · Mzouzias@equity-med.com
Study contacts (from the official record)
- Tracy Ji · +86 18001322760 · Tracy.Ji@bambusatx.com
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