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The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T0001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T0001,10mg | Drug |
| ||
| T0001,20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerance Dose | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 3 weeks | |
| pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc) | Pre-dose,2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang wei | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Fang Yi, Ph.D | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I laboratory of Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| T0001,35mg | Drug |
|
| T0001,50mg | Drug |
|
| T0001,65mg | Drug |
|
| T0001,75mg | Drug |
|