Phase
Condition
N/ATreatment
BBT002
Placebo
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Linear Clinical Research
Perth, Western Australia 6009
AustraliaActive - Recruiting
Momentum Clinical Research
Brisbane, 4068
AustraliaActive - Recruiting
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0198
GeorgiaActive - Recruiting
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, 0198
GeorgiaActive - Recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0198
GeorgiaActive - Recruiting
Ltd Aversi Clinic
Tbilisi, 0198
GeorgiaActive - Recruiting
Momentum Clinical Research Hamilton
Rotorua, Hamilton 3010
New ZealandSite Not Available
Momentum Clinical Research
Pukekohe, 2120
New ZealandActive - Recruiting
Momentum Clinical Research
Wellington, 6021
New ZealandActive - Recruiting
Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz
Gdansk, 80-214
PolandSite Not Available
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, 31-011
PolandSite Not Available
Equity Medical Bowling Green
Bowling Green, Kentucky 42104
United StatesActive - Recruiting
Equity Medical - Owensboro
Owensboro, Kentucky 42303
United StatesSite Not Available
Equity Medical LLC
New York, New York 10023
United StatesActive - Recruiting

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