Condition: Chronic Obstructive Pulmonary Disease · Sponsor: Bambusa Therapeutics
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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 description comes directly from the study's public registry record.
Tracy Ji · +86 18001322760 · Tracy.Ji@bambusatx.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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 COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G) 2. 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) 3. Negative pregnancy tests for women of childbearing potential 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 contraception use (for men and women of childbearing potential) 7. 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) 1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV) 2. Immunodeficiencies, autoimmune 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 Electrocardiogram(ECG) findings 7. History of drug/alcohol abuse in the past 2 years 8. History of severe allergic reactions or hypersensitivity 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. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP 2. Sinonasal surgery (recent/extensiv) 3. Consitions interfering with nasal assessments 4. Excluded sinonasal/systemic diseases
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Equity Medical Bowling Green | Bowling Green, Kentucky, United States | Recruiting |
| Equity Medical - Owensboro | Owensboro, Kentucky, United States | Not Yet Recruiting |
| Equity Medical LLC | New York, New York, United States | Recruiting |
| Linear Clinical Research | Perth, Western Australia, Australia | Recruiting |
| Momentum Clinical Research | Brisbane, Australia | Recruiting |
| Aleksandre Aladashvili Clinic LLC | Tbilisi, Georgia | Recruiting |
| Geo Hospitals Tbilisi Multiprofile Medical Center | Tbilisi, Georgia | Recruiting |
| LEPL The First University Clinic of Tbilisi State Medical University | Tbilisi, Georgia | Recruiting |
| Ltd Aversi Clinic | Tbilisi, Georgia | Recruiting |
| Momentum Clinical Research Hamilton | Rotorua, Hamilton, New Zealand | Not Yet Recruiting |
| Momentum Clinical Research | Pukekohe, New Zealand | Recruiting |
| Momentum Clinical Research | Wellington, New Zealand | Recruiting |
+ 2 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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