Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
Running, not enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Hypertriglyceridemia, Familial Chylomicronemia Syndrome
In brief
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.
Key facts
- Study ID
- NCT06471543
- Run by
- Ikaria Bioscience Pty Ltd
- People needed
- 108
- Starts
- 2024-09-30
- Expected to finish
- 2026-08-26
- Last updated by the study team
- 2025-12-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- TBC Research LLC, — Tamarac, Florida, United States
- Versailles Family Medicine / Avacare — Versailles, Kentucky, United States
- Axis Clinicals USA — Dilworth, Minnesota, United States
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.