The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
72
Ascending dose
Ascending dose
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
To assess the number of subjects with adverse events (AEs)
Time frame: up to day 190
To assess the number of subjects with serious adverse events (SAEs)
Time frame: up to day 190
To assess AUC0-t
Time frame: up to day 190
To assess AUC0-∞
Time frame: up to day 190
To assess Tmax
Time frame: up to day 190
To assess Cmax
Time frame: up to day 190
To assess t1/2
Time frame: up to day 190
To assess CL/F
Time frame: up to day 190
To assess 、V/F.
Time frame: up to day 190
To assess LDL-C
Time frame: up to day 190
To assess TC
Time frame: up to day 190
To assess HDL-C
Time frame: up to day 190
To assess TG
Time frame: up to day 190
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To assess ApoB
Time frame: up to day 190
To assess ApoA1
Time frame: up to day 190
To assess Lp(a)
Time frame: up to day 190
To assess VLDL-C.
Time frame: up to day 190
To assess ADA(or/and Nab).
Time frame: up to day 190