This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
99
Medpace CPU
Cincinnati, Ohio, United States
Frequency and severity of adverse events
Time frame: Screening to End of study (up to 4 weeks following randomization)
AUCinf of CAT-2003
Time frame: Days 1, 7 and 14
Cmax of CAT-1004
Time frame: Days 1, 7 and14
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Time frame: Baseline through End of study (up to 4 weeks)
Changes from baseline for Physical exams
Time frame: Baseline through end of study (up to 4 weeks)
Changes from baseline for ECGs
Time frame: Baseline through end of study (up to 4 weeks)
Changes from baseline in vital signs
Time frame: Baseline through end of study (up to 4 weeks)
Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia
Time frame: Baseline to end of study (up to 4 weeks)
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