Chronic Obstructive Pulmonary Disease
Conditions
Brief 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.
Interventions
DRUGBBT002
BBT002 will be administered.
DRUGPlacebo
Placebo will be administered.
Sponsors
Bambusa Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters- - Elimination Half-life (t1/2). | At specified timepoints pre-dose and up to 169 days post first dose administration | Elimination half-life of the study drug in serum will be analyzed for all subjects |
| PK parameters- maximum observed concentration (Cmax) | At specified timepoints pre-dose and up to 169 days post first dose administration | Maximum observed concentration of the study drug in serum will be analyzed for all subjects |
| The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). | At specified timepoints pre-dose and up to 169 days post first dose administration | Serum Anti-Drug Antibodies will be analyzed for all subjects |
| PK parameters- Time of maximum observed Concentration (Tmax) | At specified timepoints pre-dose and up to 169 days post first dose administration | Serum PK Tmax will be analyzed for all subjects |
| PK parameters- Area under the curve (AUC) | At specified timepoints pre-dose and up to 169 days post first dose administration | Area under the curve of the study drug in serum will be analyzed for all subjects |
| PK parameters- Volume of distribution (Vz) | At specified timepoints pre-dose and up to 169 days post first dose administration | Volume of distribution of the study drug in serum will be analyzed for all subjects |
| PK parameters- Total clearance (CL) | At specified timepoints pre-dose and up to 169 days post first dose administration | Total clearance of the study drug in serum will be analyzed for all subjects |
Countries
Australia, Georgia, New Zealand, Poland, United States
Contacts
CONTACTTracy Ji
STUDY_DIRECTORTracy Ji
Bambusa Therapeutics, Inc.
Outcome results
None listed