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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people
Subcutaneous injection of different doses for healthy people
Peking University People's Hospital
Beijing, Beijing Municipality, China
AUC
AUC
Time frame: 28 days
Cmax
Cmax
Time frame: 28 days
Cmin
Cmin
Time frame: 28 days
Tmax
Tmax
Time frame: 28 days
Serum creatinine and AST and ALT
Serum creatinine and AST and ALT
Time frame: 28 days
or any other adverse events
or any other adverse events
Time frame: 28 days
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