Clinical Trial: A 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
Study Status: Completed
Recruit Status: RECRUITING
Condition: Hypoxic-Ischemic Encephalopathy
Study Type: INTERVENTIONAL
Official Title: 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 Newbor
Brief Summary:
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States.Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability.Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE.RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE.This study is designed to evaluate the safety and…
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