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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1
Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiangsheng, China
Shanghai General Hospital
Shanghai, China
Cmax
Time frame: 57 days
AUC
Time frame: 57 days
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