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Study identifier: NCT05778188 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Hypoxic-Ischemic Encephalopathy  ·  Sponsor: ReAlta Life Sciences, Inc.

PhasePhase 2
Planned participants70
Who can joinAll sexes, N/A to 10 Hours
Healthy volunteersNo

About this study

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 tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

This description comes directly from the study's public registry record.

Talk to the study team

Lori Upham  ·  757-901-0331  ·  Lupham@realtals.com

Always discuss trial participation with your own doctor first.

Locations (15)

Study Site 016Little Rock, Arkansas, United StatesRecruiting
Study Site 013Orange, California, United StatesRecruiting
Study Site 020San Diego, California, United StatesRecruiting
Study Site 019San Diego, California, United StatesRecruiting
Study Site 001Gainesville, Florida, United StatesRecruiting
Study Site 018Miami, Florida, United StatesRecruiting
Study Site 010Orlando, Florida, United StatesRecruiting
Study Site 014Indianapolis, Indiana, United StatesRecruiting
Study Site 012Lexington, Kentucky, United StatesWithdrawn
Study Site 002Boston, Massachusetts, United StatesRecruiting
Study Site 006St Louis, Missouri, United StatesRecruiting
Study Site 003Durham, North Carolina, United StatesRecruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05778188