This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple times once daily to healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Investigational drug
Placebo
Research Site
Glendale, California, United States
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE will be defined as any AE that emerges during treatment (i.e., AE which starts during or after study drug administration or pre-existed and worsened in severity after study drug administration), and those will be analyzed for the purpose of safety analysis. The number of participants who experience a TEAE will be reported.
Time frame: up to Day 56
Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Peak plasma concentration (Cmax)
Time frame: up to Day 56
Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Time of peak plasma concentration (Tmax)
Time frame: up to Day 56
Area Under the Concentration-Time Curve of CKD-508 after single dose
Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUC0-24h) after a single dose
Time frame: up to 24 hours post-dose
Area Under the Concentration-Time Curve of CKD-508 after multiple doses
Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUCtau.ss) after multiple doses
Time frame: up to Day 56
Change from baseline in CETP activity after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in CETP activity measured in blood after multiple doses of CKD-508 or placebo
Time frame: up to Day 56
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Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in LDL-C measured in blood after multiple doses of CKD-508 or placebo
Time frame: up to Day 40
Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in HDL-C measured in blood after multiple doses of CKD-508 or placebo
Time frame: up to Day 40
Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in CETP protein concentration measured in blood after multiple doses of CKD-508 or placebo
Time frame: up to Day 56
The effects on the cardiac repolarization by assessing the QTc interval after single and multiple doses of CKD-508 or placebo
Time frame: up to Day 56