This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B. Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles. Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Intravenous infusion
The second affiliated hosipital zhejiang university school of medicine
Hangzhou, Zhejiang, China
Incidents of AE (including SAE)
including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG
Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)
DEQ scores
Drug effect questionnaire
Time frame: from baseline to day2 of second or third cycle(each cycle is 4 days)
OWS scores
Opiate Withdrawal Scale
Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)
AUC0-t
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
AUC0-∞
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Cmax
Pharmacokinetic index
Time frame: baseline and within 24hours after administration
Tmax
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
T1/2
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
CL
Pharmacokinetic index
Time frame: baseline and within24 hours after administration
Vd
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
MRT
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
λz
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Cold Pain Test
Pharmacodynamic index
Time frame: baseline and within 8 hours after administration
Pupillometry
Pharmacodynamic index
Time frame: baseline and within 8 hours after administration
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