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Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
Sponsor: Ikaria Bioscience Pty Ltd
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
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