This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in hypercholesterolemia subjects.
Totally about 30-50 qualified subjects were assigned to one of the following dose groups:20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of the dose groups will include 10 subjects (8 for DC739 and 2 for placebo). Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or placebo on day 1 and then treat for 28 days. Subjects from different dose groups were enrolled in turn, the next dose group is conducted on the premise that the D15 safety evaluation was completed after the administration of the previous dose group with the result was tolerance. Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after administration for pharmacokinetic data analysis. Blood lipid will be collected for effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
Participants received one of 5 dose levels of DC371739 administered as single oral doses.
Placebo orally administered as comparison
The First Hospital of Jilin University
Changchun, Jilin, China
tolerability evaluation
12-lead ECG
Time frame: From informed consent until Day 42.
Safety evaluation
adverse events (AE/SAEs)
Time frame: From informed consent until Day 42.
Pharmacodynamic evaluation
Cmax
Time frame: From informed consent until Day 31.
Effective evaluation
LDL-C
Time frame: From informed consent until Day 29.
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