This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
Eccogene Investigational Site
Las Vegas, Nevada, United States
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Time frame: SAD: Up to 8 days and MAD: Up to 21 days
Pharmacokinetic Parameters: AUC0-24
AUC from time 0 to 24 hour dosing interval
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-tlast
AUC from time 0 to the time of last quantifiable non-zero concentration
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: AUC0-tau
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Time frame: MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-infinity
AUC from time 0 extrapolated to infinity
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: Cmax
Maximum observed plasma concentration
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: C24
Observed concentration at 24 hours post dose
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Ctau
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Observed concentration at the end of the dosing interval
Time frame: MAD: Up to Day 21.
Pharmacokinetic Parameters: tmax
Time of the maximum observed plasma concentration
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: tlag
Lag time (time delay between dosing and first observed plasma concentration)
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: t1/2
Apparent terminal elimination half-life
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Clast
Last measurable non-zero concentration
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: tlast
Time of last measurable non-zero concentration
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: CL/F
Apparent Clearance
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: LDL-C
Measurement of Low Density Lipoprotein Cholesterol
Time frame: SAD: Up to Day 8
Pharmacodynamic assessment: HDL-C
Measurement of High Density Lipoprotein Cholesterol
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: TG
Measurement of Triglycerides
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: TC
Measurement of Total Cholesterol
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: LDL
Measurement of Low Density Lipoprotein
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: VLDL
Measurement of Very Low Density Lipoprotein
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: ApoB
Measurement of Apolipoprotein B
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: Lp(a)
Measurement of Lipoprotein (a)
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: Glucose
Measurement of Glucose
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: Serum Insulin
Measurement of Serum Insulin
Time frame: MAD: Up to Day 21.
Thyroid function assessment: TT3
Measurement of Total Triiodothyronine
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT3
Measurement of Free Triiodothyronine
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TT4
Measurement of Total Thyroxine
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT4
Measurement of Free Thyroxine
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TSH
Measurement of Thyroid Stimulating Hormone
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.