This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
106
Number of adverse Events
Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;
Time frame: Day-2 to last follow-up
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t);
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax
Maximum observed concentration (Cmax);
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax
Time to maximum observed concentration (Tmax);
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2
Terminal elimination half-life (t1/2)
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - CL/F
Apparent clearance (CL/F);
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz/F
Apparent volume of distribution (Vz/F);
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Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss
Area under the plasma concentration-time curve from time zero to tau at steady state (AUC0-τ,ss)
Time frame: pre-last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss
AUC0-t at steady state (AUC0-t,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss
AUC0-∞ at steady state (AUC0-∞,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss
Tmax at steady state (Tmax,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss
Cmax at steady state (Cmax,ss)
Time frame: pre- last doseto 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss
Ctrough at steady state (Ctrough,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss
Cavg at steady state (Cavg,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - DF
Degree of fluctuation at steady state (DF)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F
Vz/F at steady state (Vz,ss/F)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - CLss/F
CL/F at steady state (CLss/F)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss
t1/2 at steady state (t1/2,ss)
Time frame: pre- last dose to 96 hours post- last dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine
Time frame: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - HbA1c
Time frame: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - 5-points glucose profile
Time frame: pre-dose up to 24 hours after the last dose
PD profile of multiple doses of HRS-7535 - weight
Time frame: pre-dose up to 96 hours after the last dose