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NCT Number: NCT06471543

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of the Sunshine Coast Clinical Trials, Morayfield, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RN0361

Drug

Placebo

Primary outcomes

  1. Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects.

    Time frame: Up to Day85

    Phase 1

  2. Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG

    Time frame: Up to Day183

    Phase 2

Secondary outcomes

  1. Plasma pharmacokinetics (PK) parameters (Cmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  2. Plasma pharmacokinetics (PK) parameters (Tmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  3. 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.

    Time frame: Up to 48 hours post-dose

    Phase 1

  4. Plasma pharmacokinetics (PK) parameters (t1/2) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  5. Plasma pharmacokinetics (PK) parameters (AUC0-inf) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  6. Plasma pharmacokinetics (PK) parameters (Vz/F) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  7. Plasma pharmacokinetics (PK) parameters (λz) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to 48 hours post-dose

    Phase 1

  8. Urine pharmacokinetics (PK) parameters (CLR) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  9. Urine pharmacokinetics (PK) parameters (Aet) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  10. Urine pharmacokinetics (PK) parameters (Aeu) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  11. Urine pharmacokinetics (PK) parameters (FE) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  12. Absolute and percent change from baseline in APOC3 in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  13. Absolute and percent change from baseline in TG in adult healthy subjects.

    Time frame: Up to Day 85

    Phase 1

  14. Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in subjects with HTG.

    Time frame: Up to Day 183

    Phase 2

  15. Absolute and percent change from baseline in remnant cholesterol and VLDL-C in subjects with HTG.

    Time frame: Up to Day 183

    Phase 2

Sponsors and collaborators

Lead sponsor

Ikaria Bioscience Pty Ltd

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-controlled, Single Ascending Dose and Phase 2 Randomized, Placebo Controlled, Parallel-Group, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects, and Immunogenicity of RN0361 in Adult Healthy Subjects and Hypertriglyceridemic Subjects

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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