NCT06471543

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Ikaria Bioscience Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertriglyceridemia
• Familial Chylomicronemia Syndrome

Interventions

Type	Name	Description
DRUG	RN0361	Placebo

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-06-03
• Completion: 2026-08-26
• First posted: 2024-06-24
• Last updated: 2025-12-30

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study