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Active, not recruiting Phase 1/2

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

NCT06471543 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2024-09-30
Last updated
2025-12-30

Condition(s) studied

HypertriglyceridemiaFamilial Chylomicronemia Syndrome

Investigational drug(s) / intervention(s)

RN0361

RN0361: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Phase I: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels \> 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. * Participants must avoid sperm or egg donation during the study Exclusion Criteria: * History or presence of any serious or uncontrolled disease * clinically significant health concerns * Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study. * Positive tests for alcohol or drugs of abuse at screening. * History of multiple drug allergies or allergic reactions to specific components used in the study. Phase II: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels ≥ 300 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. Exclusion Criteria: * History or presence of any serious or uncontrolled disease * Active pancreatitis within 12 weeks prior to Day 1 * Uncontrolled hypertension (sitting blood pressure) \>160/100 mm Hg * Uncontrolled diabetes * Symptomatic heart failure (NYHA II-IV) * Positive serologic test of HBV, HCV, or HIV * Alcohol or drugs abuse * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc. * History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc) * History of malignancy within the last 2 years prior to the date of consent Note: Additional inclusion/exclusion ceiteria may apply, per protocol.

Primary outcome measure(s)

  • Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects. — Up to Day85
    Phase 1
  • Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG — Up to Day183
    Phase 2

Trial sites (10)

FacilityCityRegionStatus
TBC Research LLC, Tamarac Florida
Versailles Family Medicine / Avacare Versailles Kentucky
Axis Clinicals USA Dilworth Minnesota
Synergy Groups Medical Houston Texas
Tranquil Webster Texas
Ogden Clinic, Mountain View / Avacare Pleasant View Utah
University of the Sunshine Coast Clinical Trials Morayfield Queensland
University of the Sunshine Coast Clinical Trials, Sippy Downs Sippy Downs Queensland
Altona Clinical Research Altona N. Victoria
Nucleus Network Melbourne Melbourne Victoria
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471543 on ClinicalTrials.gov ↗ ← All trials in the USA