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The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.
This study is a randomized, open-label, parallel-designed comparative pharmacokinetic study to evaluate the biosimilarity between the formulations of 611.A total of about 180 healthy adult subjects in China were planned to be included, and the qualified subjects were randomly stratified according to the research center, body weight (≥65kg, <65kg), and randomly assigned to the test preparation group and the reference preparation group at a ratio of 1:1, and received a single subcutaneous injection of 300 mg of the experimental drug according to their group. Blood was collected on D1 and D2, D3, D4, D5, D6, D7, D8, D15, D22, D29, D43 and D57 after administration, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tested preparation group | Experimental | Healthy subjects will receive new formulations of 611 300mg once |
|
| Reference preparation group | Experimental | Healthy subjects will receive existing formulations of 611 300mg once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new formulations of 611 | Drug | Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 57 days | |
| AUC | 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Zhou | Contact | +86 18911301578 | zhouqinghong@3sbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiangsheng | 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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| existing formulations of 611 | Drug | Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1 |
|
| Shanghai General Hospital | Shanghai | China |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |