Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
This study is a randomized, double-Blind, placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
The study consists of two parts: * Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (two repeated doses in patients with COPD, MAD in patients part)
Interventions
DRUGBBT002
BBT002 will be administered
DRUGPlacebo
Placebo will be administered
Sponsors
Bambusa Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
( A\&B) 1. Age of 18-65 years (HVs), 35-75 years (patients) 2. Body mass index between 18-32 kg/m², capped at 120 kg 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 B only) 1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70 2. FEV1 ≥ 30% and FEV1\<80% predicted at screening.
Exclusion criteria
( part A \& B) 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 | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration | Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0. |
| Number of participants with change in Laboratory assessments | Part A- Up to Day 141; Part B - Up to Day 169 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. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration | Blood pressure and heart rate will be assessed. |
| Number of participants with change in physical examination following dose administration. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration | Physical examination will be assessed. |
| Number of participants with change in 12-lead ECG readings | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration | 12-lead ECG will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| PK parameters- Time for 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 |
| 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 |
| 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 subject |
Countries
China
Contacts
CONTACTTracy Ji, Study Director
Outcome results
None listed