Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Last updated: May 29, 2025
Sponsor: Ikaria Bioscience Pty Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Familial Chylomicronemia Syndrome

Hypertriglyceridemia

Treatment

RN0361

Clinical Study ID

NCT06471543
RN0361-101
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 InformedConsent Form and the protocol.

  • Fasting serum triglyceride levels > 80 mg/dL and fasting LDL-C ≥70 mg/dL atscreening

  • Female participants must either be nonchildbearing or, if of childbearing potential,not pregnant, not breastfeeding, and using effective contraception. Maleparticipants must use condoms and ensure their partners use contraception if theyare of childbearing potential.

  • Participants must avoid sperm or egg donation during the study

Exclusion

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 receivesuch during the study.

  • Positive tests for alcohol or drugs of abuse at screening.

  • History of multiple drug allergies or allergic reactions to specific components usedin 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 InformedConsent 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. Maleparticipants must use condoms and ensure their partners use contraception if theyare 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 anoligonucleotide 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.

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: RN0361
Phase: 1/2
Study Start date:
September 30, 2024
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • University of the Sunshine Coast Clinical Trials

    Morayfield, Queensland
    Australia

    Site Not Available

  • University of the Sunshine Coast Clinical Trials, Sippy Downs

    Sippy Downs, Queensland 4556
    Australia

    Site Not Available

  • Altona Clinical Research

    Altona N., Victoria 3025
    Australia

    Site Not Available

  • Nucleus Network Melbourne

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Lifeline Primary Care/Avacare

    Lilburn, Georgia 30047
    United States

    Site Not Available

  • Versailles Family Medicine / Avacare

    Versailles, Kentucky 40383
    United States

    Site Not Available

  • Axis Clinicals USA

    Dilworth, Minnesota 56529
    United States

    Site Not Available

  • Tranquil

    Webster, Texas 77598
    United States

    Site Not Available

  • Ogden Clinic, Mountain View / Avacare

    Pleasant View, Utah 84404
    United States

    Site Not Available

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