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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).
The study consists of two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Single Ascending Dose BBT002 | Experimental | A single dose of BBT002 will be administered in healthy volunteers |
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| Part B Multiple Ascending Dose BBT002 | Experimental | Two doses of BBT002 will be administered in patients with COPD. |
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| Part A Single Ascending Dose Placebo | Placebo Comparator | A single dose of Placebo will be administered in healthy volunteers. |
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| Part B Multiple Ascending Dose Placebo | Placebo Comparator | Two doses of Placebo will be administered in patients with COPD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBT002 | Drug | BBT002 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events following single and multiple administration of BBT002 | Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Number of participants with change in Laboratory assessments | Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Number of participants with change in vital sign measurements following dose administration. | Blood pressure and heart rate will be assessed. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Number of participants with change in physical examination following dose administration. | Physical examination will be assessed. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Number of participants with change in 12-lead ECG readings | 12-lead ECG will be assessed. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters- maximum observed concentration (Cmax) | Maximum observed concentration of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| PK parameters- Time for maximum observed Concentration (Tmax) |
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Inclusion Criteria:( A&B)
Key Inclusion Criteria (Part B only)
Exclusion Criteria:( part A & B)
Key Exclusion Criteria for (Part B only)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Ji, Study Director | Contact | +86 18001322760 | tracy.ji@bambusatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical Univesity | Recruiting | Hefei | Anhui | 230601 | China |
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| Placebo | Drug | Placebo will be administered |
|
Serum PK Tmax will be analyzed for all subjects |
| At specified timepoints pre-dose and up to 169 days post first dose administration |
| PK parameters- Area under the curve (AUC) | Area under the curve of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| PK parameters- Volume of distribution (Vz) | Volume of distribution of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| PK parameters- Total clearance (CL) | Total clearance of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| PK parameters- - Elimination Half-life (t1/2) | Elimination half-life of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). | Serum Anti-Drug Antibodies will be analyzed for all subject | At specified timepoints pre-dose and up to 169 days post first dose administration |
| The third affiliated hosptial of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 020-81292183 | China |
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| The First Affiliated Hospital of Guangdong Medical University | Active, not recruiting | Guangzhou | Guangdong | 510000 | China |
| Jiangmen Central Hospital | Not yet recruiting | Jiangmen | Guangdong | 529000 | China |
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| Qingyuan People's Hospital | Not yet recruiting | Qingyuan | Guangdong | China |
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| The First People's Hospital of Xinxiang City | Not yet recruiting | Xinxiang | Henan | 453000 | China |
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| Yichang Central People's Hospital | Not yet recruiting | Yichang | Hubei | 443000 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221002 | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| Chengdu fifth People's Hospital | Not yet recruiting | Chengdu | Sichuang | 611130 | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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