This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Investigational drug
Placebo
Investigational drug
Northwick Park Hospital
Harrow, Middlesex, United Kingdom
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
Time frame: 28 days post the final dose
Maximum plasma CKD-508 concentrations after dosing
Peak plasma concentration (Cmax)
Time frame: 28 days post the final dose
Time of maximum plasma CKD-508 concentrations after dosing
Time of peak plasma concentration (Tmax)
Time frame: 28 days post the final dose
Changes from baseline in plasma CKD-508 concentrations in time after dosing
Area under the plasma concentration versus time curve (AUC)
Time frame: 28 days post the final dose
Changes from baseline in CETP activity after dosing
Pharmacodynamics endpoint
Time frame: 28 days post the final dose
Changes from baseline in lipid parameters after dosing
including, but not limited to the following: LDL-C, etc. Pharmacodynamics endpoint
Time frame: 14 days post the final dose
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Placebo