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)
Recruiting · NCT06944925 · Interventional (participants receive a specific treatment) · Lead sponsor: Bambusa Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
BBT002Placebo
What this trial 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).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed across 2 US states.
- Equity Medical Bowling Green - Bowling Green, Kentucky, United States
- Equity Medical - Owensboro - Owensboro, Kentucky, United States
- Equity Medical LLC - New York, New York, United States
- Momentum Clinical Research - Brisbane, Australia
- Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz - Gdansk, Poland
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. - Krakow, Poland
- Momentum Clinical Research - Pukekohe, New Zealand
- Aleksandre Aladashvili Clinic LLC - Tbilisi, Georgia
- Geo Hospitals Tbilisi Multiprofile Medical Center - Tbilisi, Georgia
- LEPL The First University Clinic of Tbilisi State Medical University - Tbilisi, Georgia
- Ltd Aversi Clinic - Tbilisi, Georgia
- Momentum Clinical Research - Wellington, New Zealand
- Momentum Clinical Research Hamilton - Rotorua, Hamilton, New Zealand
- Linear Clinical Research - Perth, Western Australia, Australia