The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Pre-test: Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0)
Time frame: Day-1 to Day 46
Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-inf
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: the geometric mean ration
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: 90% confidence interval (90% CI) of AUC0-inf
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Pre-test: Inter-individual coefficient of variation (CV) of the AUC0-inf of SHR-1210
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Cmax
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Tmax
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Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: t1/2
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: CL
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Vss
Time frame: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9
Formal Test: The incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab) for SHR-1210
Time frame: Based on sampling times pre-dose on Day1, post-dose on Day 9 and Day 16
Formal Test: Incidence and severity of adverse events (rated based on CTCAE 5.0)
Time frame: Day-1, Day 1 to Day 46±7