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 (STAR)

This study is being conducted to learn whether the investigational medication, called RLS-0071, may help babies, such as your own, who are affected by hypoxic-ischemic encephalopathy (HIE). HIE is a disease process where the baby’s brain has suffered from not enough blood and oxygen and the baby is at risk for injury to the brain. In addition to the standard of care for HIE, whole body cooling to help reduce brain injury, babies in this study may receive an investigational medication called RLS-0071. An investigational medication means that it has not been approved by the United States (US) Food and Drug Administration (FDA) to be sold to the public. The FDA is the governmental agency in the United States responsible for approving new medications/devices.