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)
Start Date
5/8/2025
Completion Date
7/31/2027
Summary
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).
Detailed Description
This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
BBT002
Placebo
Conditions
Locations
Equity Medical Bowling Green
Bowling Green, Kentucky 42104
United States
Equity Medical - Owensboro
Owensboro, Kentucky 42303
United States
Equity Medical LLC
New York, New York 10023
United States
Linear Clinical Research
Perth, Western Australia 6009
Australia
Momentum Clinical Research
Brisbane, 4068
Australia
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0198
Georgia
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, 0198
Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0198
Georgia
Ltd Aversi Clinic
Tbilisi, 0198
Georgia
Momentum Clinical Research Hamilton
Rotorua, Hamilton 3010
New Zealand
Momentum Clinical Research
Pukekohe, 2120
New Zealand
Momentum Clinical Research
Wellington, 6021
New Zealand
Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz
Gdansk, 80-214
Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, 31-011
Poland