The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections
calculated volume to match active treatment
Research Site 2
Camperdown, New South Wales, Australia
Research Site 3
Adelaide, South Australia, Australia
Research Site 1
Nedlands, Australia
Research Site 4
Grafton, Auckland, New Zealand
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time frame: Up to 113 (+/- 3 days) post-dose
Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)
Time frame: Single dose phase: Up to 48 hours post-dose
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Time frame: Baseline, Up to Day 113 (+/- 3 days)
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Research Site 5
Papatoetoe, Aukland, New Zealand
Research Site 6
Christchurch, New Zealand