The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections
calculated volume to match active treatment
Research Site 2
Camperdown, New South Wales, Australia
Research Site 5
Sippy Downs, Queensland, Australia
Research Site 3
Adelaide, South Australia, Australia
Research Site 4
Perth, Washington, Australia
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time frame: Up to Day 113 (+/- 3 days)
Pharmacokinetics (PK) of ARO-APOC3 in Normal Healthy Volunteers (NHVs): Maximum Observed Plasma Concentration (Cmax)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-APOC3 in NHVs: Time to Maximum Plasma Concentration (Tmax)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-APOC3 in NHVs: Terminal Elimination Half-Life (t1/2)
Time frame: Single dose phase: Up to 48 hours post-dose
PK of ARO-APOC3 in NHVs: 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-APOC3 in NHVs: 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 APOC3 from Pre-Dose Baseline
Time frame: Up to Day 113 (+/- 3 days)
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Research Site 7
London, Ontario, Canada
Research Site 6
Chicoutimi, Quebec, Canada
Research Site 8
Montreal, Quebec, Canada
Research Site 9
Grafton, Auckland, New Zealand
Research Site 10
Papatoetoe, Auckland, New Zealand
Research Site 11
Christchurch, New Zealand