This is a Phase 1, randomized, double blind, third party open (i.e., participant blind, investigator blind and sponsor open), placebo controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamics of vupanorsen in Japanese healthy adult participants with elevated triglycerides.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
12
80 mg subcutaneous injection
Subcutaneous injection
P-one Clinic
Hachioji-shi, Tokyo, Japan
Incidence of treatment related adverse events
Time frame: Day 0-90
Incidence of abnormal and clinically relevant changes in electrocardiogram
Time frame: Day 0-90
Incidence and magnitude of abnormal laboratory findings
Time frame: Day 0-90
Incidence of abnormal and clinically relevant changes in pulse rate
Time frame: Day 0-90
Incidence of abnormal and clinically relevant changes in supine blood pressure
Time frame: Day 0-90
Maximum observed plasma concentration (Cmax)
Time frame: Day 0-90
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day 0-90
Area under the plasma concentration-time profile from time zero to 24 hours post-dose (AUC24h)
Time frame: Day 0-90
Area under the plasma concentration-time profile from time zero to 48 hours post-dose (AUC48h)
Time frame: Day 0-90
Area under the plasma concentration-time profile from time zero to the last measurable concentration (AUClast)
Time frame: Day 0-90
Area under the plasma concentration-time profile from time zero to infinity (AUCinf)
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Time frame: Day 0-90
Terminal elimination half life (t1/2)
Time frame: Day 0-90
Apparent volume of distribution (Vz/F)
Time frame: Day 0-90
Apparent clearance (CL/F)
Time frame: Day 0-90
Percentage changes from baseline in serum angiopoietin-like protein 3
Time frame: Day 0-90
Percentage changes from baseline in total cholesterol
Time frame: Day 0-90
Percentage changes from baseline in low density lipoprotein cholesterol
Time frame: Day 0-90
Percentage changes from baseline in non-high-density lipoprotein cholesterol
Time frame: Day 0-90
Percentage changes from baseline in very low density lipoprotein cholesterol
Time frame: Day 0-90
Percentage changes from baseline in triglyceride
Time frame: Day 0-90
Percentage changes from baseline in apolipoprotein A-1
Time frame: Day 0-90
Percentage changes from baseline in apolipoprotein B total
Time frame: Day 0-90
Percentage changes from baseline in apolipoprotein C-III
Time frame: Day 0-90