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A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up

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Trial Profile

A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs Pegtarazimod (Primary)
  • Indications Brain hypoxia-ischaemia; Encephalopathy
  • Focus Adverse reactions
  • Acronyms STAR
  • Sponsors ReAlta Life Sciences

Most Recent Events

  • 25 Apr 2025 According to a ReAlta Life Sciences media release, Biomarker an Pharmacokinetics data from the ongoing Phase 2 STAR trial to be presented at the Pediatric Academic Societies (PAS) Annual Meeting, taking place April 24-28, 2025 in Honolulu, Hawaii.
  • 25 Apr 2025 Results published in the ReAlta Life Sciences Media Release.
  • 08 Apr 2025 According to ReAlta Life Sciences media release, this trial is currently enrolling patients at 13 NICUs across the U.S

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