The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Placebo
TBC Research LLC,
Tamarac, Florida, United States
Versailles Family Medicine / Avacare
Versailles, Kentucky, United States
Axis Clinicals USA
Dilworth, Minnesota, United States
Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects.
Phase 1
Time frame: Up to Day85
Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG
Phase 2
Time frame: Up to Day183
Plasma pharmacokinetics (PK) parameters (Cmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Plasma pharmacokinetics (PK) parameters (Tmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Plasma pharmacokinetics (PK) parameters (AUC 0-24) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Plasma pharmacokinetics (PK) parameters (t1/2) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Plasma pharmacokinetics (PK) parameters (AUC0-inf) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
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Synergy Groups Medical
Houston, Texas, United States
Tranquil
Webster, Texas, United States
Ogden Clinic, Mountain View / Avacare
Pleasant View, Utah, United States
University of the Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, Australia
Altona Clinical Research
Altona N., Victoria, Australia
Nucleus Network Melbourne
Melbourne, Victoria, Australia
Plasma pharmacokinetics (PK) parameters (Vz/F) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Plasma pharmacokinetics (PK) parameters (λz) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to 48 hours post-dose
Urine pharmacokinetics (PK) parameters (CLR) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Urine pharmacokinetics (PK) parameters (Aet) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Urine pharmacokinetics (PK) parameters (Aeu) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Urine pharmacokinetics (PK) parameters (FE) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Absolute and percent change from baseline in APOC3 in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Absolute and percent change from baseline in TG in adult healthy subjects.
Phase 1
Time frame: Up to Day 85
Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in subjects with HTG.
Phase 2
Time frame: Up to Day 183
Absolute and percent change from baseline in remnant cholesterol and VLDL-C in subjects with HTG.
Phase 2
Time frame: Up to Day 183