This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
HRS-1780 table or placebo single dose
HRS-1780 table or placebo single dose with food effect
HRS-1780 table or placebo multiple dose
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets
Time frame: About a month from the first medication to the evaluation.
Assess the concentration of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of AUC0-t of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of AUC0-∞ of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of Tmax of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of Cmax of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of t1/2 of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluate the blood pressure of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the heart rate of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
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Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration
Time frame: About 4 weeks after the first dose