This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject
A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1\~8) in the study, each cohort including 10 subjects (8 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Intravenous infusion of 30min duration
Intravenous infusion of 30min duration
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 day8
DEQ
Drug effect questionnaire,
Time frame: from baseline to day2
OWS
Opiate Withdrawal Scale
Time frame: from baseline to day3
AUC0-t
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
AUC0-∞
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
Cmax
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
Tmax
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
T1/2
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
CL
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
Vd
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Pharmacokinetic index
Time frame: baseline and 48 hours after administration
MRT
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
λz
Pharmacokinetic index
Time frame: baseline and 48 hours after administration
PD profile : Cold Pain Test
Pharmacodynamic index
Time frame: baseline and 8 hours after administration
PD profile : Pupillometry
Pharmacodynamic index
Time frame: baseline and 8 hours after administration