The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
SHR-3045 injection.
SHR-3045 placebo injection.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Adverse events (AEs)
Time frame: From screening period up to day 113.
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Time frame: Post-dose at day 1 to day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
Time frame: Post-dose at day 1 to day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Time frame: Post-dose at day 1 to day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Time frame: Post-dose at day 1 to day 113.
Clearance of SHR-3045 (CL).
Time frame: Post-dose at day 1 to day 113.
Terminal elimination half-life of SHR-3045 (t1/2).
Time frame: Post-dose at day 1 to day 113.
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