A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06944925
- Lead Sponsor
- Bambusa Therapeutics
- Brief Summary
This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
- Detailed Description
The study consists of three parts:
* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
* Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)
* Part C (two repeated doses in patients with COPD, MAD in patients part)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A Single Ascending Dose BBT002 BBT002 A single dose of BBT002 will be administered in healthy volunteers Part B Multiple Ascending Dose BBT002 BBT002 Three doses of BBT002 will be administered in healthy volunteers. Part C Multiple Ascending Dose BBT002 BBT002 Two doses of BBT002 will be administered in patients with COPD. Part A Single Ascending Dose Placebo Placebo A single dose of Placebo will be administered in healthy volunteers. Part B Multiple Ascending Dose Placebo Placebo Three doses of Placebo will be administered in healthy volunteers. Part C Multiple Ascending Dose Placebo Placebo Two doses of Placebo will be administered in patients with COPD.
- Primary Outcome Measures
Name Time Method Number of participants with change in Laboratory assessments Part A- Up to Day 141; Part B and C- 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 and C- 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 and C- 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 and C- Up to Day 169 post first dose administration 12-lead ECG will be assessed.
Number of participants with adverse events following single and multiple administration of BBT002 Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method 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 subjects
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Perth, Western Australia, Australia