The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Receive a single dose of 240mg SHR-1314 at every period (First period:1mL AI, injection two needles. Second period: 2mL AI, injection one needle).
Receive a single dose of 240mg SHR-1314 at every period (First period:2mL AI, injection one needle. Second period: 1mL AI, injection two needles).
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
After a single subcutaneous injection of SHR-1314, assess injection site pain by VISUAL ANALOG SCALE at immediately after administration, 1 h, 48 h, Day 5 and Day 8, the results ranger from 0 to 10 cm, with higher scores indicating greater pain
Time frame: Day 1 to Day 8 after each administration
After a single subcutaneous injection of SHR-1314, the incidence rate of injection site reaction at 1 h, 48 h, Day 5 and Day 8
Time frame: Day 1 to Day 8 after each administration
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Time to maximum concentration (Tmax)
Time frame: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Area Under the Concentration versus time curve (AUC0-t)
Time frame: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Maximum Concentration (Cmax)
Time frame: Day 1 to Day 28
Safety indicators: The rate of adverse events (AE, including Injection site reactions), serious adverse events (SAE)
Time frame: Screening period up to Day 43
Immunogenicity indicators: The rate of anti-SHR-1314 antibodies
Time frame: Start of treatment up to Day 43
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