The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
SHR-3045 injection.
SHR-3045 placebo injection.
The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGAdverse 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.
Apparent clearance of SHR-3045 (CL/F).
Time frame: Post-dose at Day 1 to Day 113.
Apparent volume of distribution of SHR-3045 (Vz/F).
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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