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ACTIVE NOT RECRUITING
NCT06471543
PHASE1/PHASE2

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Sponsor: Ikaria Bioscience Pty Ltd

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2024-09-30

Completion Date

2026-08-26

Last Updated

2025-12-30

Healthy Volunteers

Yes

Interventions

DRUG

RN0361

Placebo

Locations (10)

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