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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 Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma.
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 | Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma |
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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 | Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBT002 | Drug | BBT002 will be administered in part A and part B |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events following single and multiple administration of BBT002 | Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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 vital sign measurements following dose administration. | Changes in vital sign measurements, physical examination, clinical laboratory test findings, and 12-lead results. | 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 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 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- 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- maximum observed concentration (Cmax) |
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Inclusion Criteria: Part (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 |
|---|---|---|---|---|---|---|
| People's Hospital of Peking University | Beijing | Beijing Municipality | 100044 | China |
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| Placebo | Drug | Placebo will be administered |
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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) | 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- 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 Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
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| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| The Second Hospital of Shandong Province | Jinan | Shandong | 250022 | China |
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| Qingdao University Hospital | Qingdao | Shandong | 266003 | China |
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| The Affiliated Yuhuangding Hospital of Qingdao University | Yantai | Shandong | 264000 | China |
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| Zibo Hospital of Shandong University | Zibo | Shandong | 255036 | China |
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| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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| The Second Hospital of Chengdu City | Chengdu | Sichuang | 610017 | China |
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| Zhejiang People's Hospital | Hangzhou | Zhejiang | 310014 | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325024 | China |
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