This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1816 after single and multiple injection with different dose regimens in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
60
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Number of adverse Events
Time frame: Day-2 to Day29/Day50
Incidence of hypoglycemic events
Time frame: Day1 to Day8/Day29
Incidence of reaction of the injection sites
Time frame: Day1 to Day8/Day29
Pharmacokinetic (PK) profile of SHR-1816 - AUC0-t
AUC0-t, area under the concentration-time curve from time 0 to the time of last quantifiable concentration;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - AUC0-inf
AUC0-inf, area under the concentration-time curve from time 0 to infinity;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - Cmax
Cmax, observed maximum concentration;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - Tmax
Tmax, time of occurrence of Cmax;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - Vz/F
Vz/F, apparent volume of distribution;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
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Pharmacokinetic (PK) profile of SHR-1816 - CL/F
CL/F, apparent clearance;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - t1/2
t1/2, terminal half-life;
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacokinetic (PK) profile of SHR-1816 - MRTinf
MRTinf, mean residence time from time 0 to infinity.
Time frame: pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose
Pharmacodynamic (PD) profile of doses of SHR-1816 - fasting blood glucose
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - insulin
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - C-peptide
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - glucagon
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - total GLP-1
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - active GLP-1
Time frame: Day-1 to Day15/Day29
Pharmacodynamic (PD) profile of doses of SHR-1816 - fructosamine
Time frame: Day-1 to Day15/Day29
PD profile of multiple doses of SHR-1816 - HbA1c
Time frame: Day-1, Day29
PD profile of multiple doses of SHR-1816 - 7-points glucose profile
Time frame: Day-1 to Day15/Day29
PD profile of multiple doses of SHR-1816 - weight
Time frame: Day-1 to Day15/Day29
Immunogenicity
Incidence of SHR-1816 antibody formation.
Time frame: Day1 to Day29/Day50