The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
Safety and tolerability will be assessed by comparison of number of adverse events between groups
Time frame: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
Maximum plasma concentration (Cmax)
Time frame: -0.5 to 120 hour after dosing
time to maximum plasma concentration (Tmax)
Time frame: -0.5 to 120 hour after dosing
area under the curve (AUC)
Time frame: -0.5 to 120 hour after dosing
half-life
Time frame: -0.5 to 120 hour after dosing
apparent volume of distribution (Vz/F)
Time frame: -0.5 to 120 hour after dosing
apparent oral clearance (CL/F) of HS-10522
Time frame: -0.5 to 120 hour after dosing
Plasma aldosterone following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
Cortisol following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
Metabolites levels following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
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(Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline
Blood pressure measurement will be performed only in MAD part
Time frame: 14 days after dosing