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This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.
This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.
The study observed blood concentrations of the experimental drug at different time points after and before administration, TNFα before and after treatment at different time points will be observed as well.
C-T curve will be drawn with blood drug concentration (c) and time (T) in the trial. At the same time, the investigators will draw the average plasma concentration curve. Compartmental and non compartmental model will be used to analyze the pharmacokinetic parameters of subjects. It will be judged with linear or nonlinear elimination by the correlation analysis of AUC, Cmax of different doses. In the meantime, adverse events, vital signs, physical examination, laboratory examination and ECG will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | The arm is as a control group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody. |
|
| experimental group | Experimental | The arm is as an experimental group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humanized TNFα monoclonal antibody | Drug | Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | AUC | 28 days |
| Cmax | Cmax | 28 days |
| Cmin | Cmin | 28 days |
| Tmax | Tmax | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine and AST and ALT | Serum creatinine and AST and ALT | 28 days |
| or any other adverse events | or any other adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| placebo | Other | Subcutaneous injection of different doses for healthy people |
|
| 28 days |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |