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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

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Trial Profile

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs RN-0361 (Primary)
  • Indications Hyperlipoproteinaemia type I; Hypertriglyceridaemia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Ikaria Bioscience

Most Recent Events

  • 25 May 2025 Protocol was amended to change phase 1 to phase 1/2, subjects with Hypertriglyceridemic were added, primary endpoint was changed, patient number was also increased and study design was changed.
  • 25 May 2025 Planned number of patients changed from 60 to 108.
  • 25 May 2025 Planned End Date changed from 30 Jun 2026 to 30 Dec 2026.

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