In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
SHR-1209 single-site subcutaneous injection.
SHR-1209 multiple-site subcutaneous injections.
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
Time frame: After injection in day 1 and day 57.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.
Time frame: After injections in day 1 and day 57.
Area under the curve (AUC0-56).
Time frame: After injection in day 1 up to day 56.
Peak time (Tmax) of SHR-1209.
Time frame: After injection in day 1 up to day 56.
Peak concentration (Cmax) of SHR-1209.
Time frame: After injection in day 1 up to day 56.
Subjects' preferred method of SHR-1209 administration between the tested injection regimens.
Time frame: Day 68.
Incidence and severity of adverse events (AEs).
Time frame: From Day 1 to Day 169.
Incidence and severity of serious adverse events (SAEs).
Time frame: From Day 1 to Day 169.
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