In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
159
SHR-1209,single subcutaneous injection of 450mg
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)
Time frame: Days 1-113
Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)
Time frame: Days 1-113
Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.
Time frame: Days 1-113
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