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This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
The study consists of two parts:
Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) Part B (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A -BBT001(Single Ascending Dose) | Experimental | A single dose of BBT001 will be administered in healthy volunteers |
|
| Part A- Placebo(Single Ascending Dose) | Experimental | A single dose of Placebo will be administered in healthy volunteers |
|
| Part B- BBT001(Multiple Ascending Dose) | Experimental | Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis |
|
| Part B -Placebo (Multiple Ascending Dose)) | Experimental | Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBT001 | Drug | BBT001 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events following single and multiple administration of BBT001 | Incidence, relatedness, and severity of adverse events graded per NCI 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 treatment 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 serum blood parameters. | Laboratory assessments include hematology, blood chemistry and coagulation test | 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 treatment 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 electrocardiogram (ECG) results measurements following treatment administration. | 12-lead ECG will be tested at individual sites using sites' equipment and will be assessed. | Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics 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. |
| Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) |
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Key Inclusion Criteria ( Part A and B):
Key Inclusion Criteria (Part B only):
Key Exclusion Criteria for (Part A&B)
Key Exclusion Criteria for (Part B only)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Ji | Contact | +86 18001322760 | tracy.ji@bambusatx.com |
| Name | Affiliation | Role |
|---|---|---|
| Tracy Ji | Bambusa (Beijing) Therapeutics Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical Univesity | Recruiting | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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 |
| Pharmacokinetics 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 |
| Pharmacokinetics 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 |
| Pharmacokinetics 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 |
| Pharmacokinetics 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 BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). | Serum Anti-Drug Antibodies will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
| The Second Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241001 | China |
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| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Dermatology Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510440 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| Wuxi Second People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214002 | China |
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| Jiangsu University Affiliated Hospital | Not yet recruiting | Zhenjiang | Jiangsu | 212001 | China |
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| Jiangxi Provincial Dermatology Hospital | Not yet recruiting | Nanchang | Jiangxi | 330000 | China |
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| Shandong Provincial Hospital for Skin Diseases | Not yet recruiting | Jinan | Shandong | 250011 | China |
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| Shanghai Dermatology Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200050 | China |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |