This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Time frame: 10 days (SAD), 41 days (MAD)
PK parameters of HRS-1597 in plasma and urine : Cmax
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Tmax
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : AUC
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CL/F
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CLR
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Vz/F
Time frame: Days 1-34
PD endpoint (Fasting blood glucose)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (Fasting serum insulin)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (Fasting C-peptide)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (HOMA-IR)of HRS-1597
Time frame: Baseline-Day 34
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.