This is a Phase I, single-dose and multiple dose escalation clinical trial for HSK31679 conducted in chinese healthy volunteers and LDL-C elevated subjects. The safety, tolerability, food-impact,pharmacokinetics and pharmacodynamics of HSK31679 tablet in healthy volunteers and LDL-C elevated volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
96
Peking University First Hospital
Beijing, Beijing Municipality, China
Xiangya Hospital of Central South University
Changsha, China
The number and severity of treatment emergent adverse events (TEAEs) .
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
Changes from baseline in clinical laboratory parameters(Blood routine, blood biochemistry, Urine routine, Coagulation function, thyroid function and antibodies).
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
Changes from baseline in physical examination results(General condition skin mucous membrane superficial lymph nodes head neck chest abdomen spine limbs and others).
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
Changes from baseline in vital signs(Systolic and diastolic blood pressure, pulse, respiratory rate, body temperature).
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
Changes from baseline in 12-ECG(QT interval, QTcF interval, PR interval, QRS interval and RR interval).
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma concentration of HSK31679
Assessed with or without food in single dose Assessed with or without stains in multiple doses
Time frame: 0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of HSK31679
Assessed with or without stains in multiple doses
Time frame: Day 1 to Day 14