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)
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Number of participants with adverse events following single and multiple administration of BBT002 — Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.
Number of participants with change in Laboratory assessments — Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Number of participants with change in vital sign measurements following dose administration. — Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following dose administration. — Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration Physical examination will be assessed.
Number of participants with change in 12-lead ECG readings — Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration 12-lead ECG will be assessed.
Trial sites (14)
Facility
City
Region
Status
Equity Medical Bowling Green
Bowling Green
Kentucky
Recruiting
Equity Medical - Owensboro
Owensboro
Kentucky
Not Yet Recruiting
Equity Medical LLC
New York
New York
Recruiting
Linear Clinical Research
Perth
Western 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
Not Yet Recruiting
Momentum Clinical Research
Pukekohe
New Zealand
Recruiting
Momentum Clinical Research
Wellington
New Zealand
Recruiting
Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz
Gdansk
Poland
Not Yet Recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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