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Evaluating a new treatment for newborns with brain injury from lack of oxygen

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

Phase 2 Interventional ReAlta Life Sciences, Inc. · NCT05778188

This study is testing a new treatment for newborns with brain injuries caused by a lack of oxygen to see if it can help them recover better while they are receiving cooling therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment70 (estimated)
AgesN/A to 10 Hours
SexAll
SponsorReAlta Life Sciences, Inc. Industry-sponsored
Locations15 sites (Little Rock, Arkansas and 14 other locations)
Trial IDNCT05778188 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071, a novel peptide, in newborns diagnosed with moderate or severe hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia. The study is designed as a Phase 2, two-stage, multisite, randomized, double-blind, placebo-controlled trial. Participants will receive either RLS-0071 or a placebo for 72 hours, followed by long-term observation until they reach 24 months of age. Safety evaluations will be conducted throughout the study to monitor any adverse effects and the drug's pharmacokinetics.

Who should consider this trial

Good fit: Ideal candidates include newborns ≥ 36 weeks gestation with moderate or severe HIE due to identifiable acute events during delivery.

Not a fit: Patients who do not meet the criteria for moderate or severe HIE or those with other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for newborns suffering from hypoxic-ischemic encephalopathy.

How similar studies have performed: While there have been studies on therapeutic hypothermia for HIE, the specific approach using RLS-0071 is novel and has not been previously tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. ≥ 36 weeks gestation.
2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.
3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):

   1. Risk of encephalopathy (either):

      * Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) or venous blood gas (VBG) (cord or infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol/L.

      OR
      * appearance, pulse, grimace, activity, and respiration (APGAR) score ≤ 5 at 10 minutes OR
      * The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal, mask ventilation, or continuous positive airway pressure \[CPAP\]).
   2. Clinical signs of encephalopathy (either/both):

      * Moderate/Severe encephalopathy on National Institute of Child Health and Human Development assessment.
      * Evidence of seizures (clinical and/or electroencephalogram).
4. Be eligible to receive therapeutic hypothermia.
5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).
6. Product of a singleton pregnancy.
7. Written informed consent obtained from parent or legal guardian.

Exclusion Criteria:

1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.
2. Known major congenital and/or chromosomal abnormality(ies).
3. Severe growth restriction (birth weight ≤ 1800 g).
4. Prenatal diagnosis of brain abnormality or hydrocephalus.
5. Patient's head circumference is \< 30 cm.
6. 10-minute APGAR score \< 2, if available.
7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment.
8. Persistent severe hypotension unresponsive to inotropic support (requiring \>2 inotropes, not inclusive of hydrocortisone).
9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO).
10. Severe disseminated intravascular coagulation with clinical bleeding.
11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE).
12. Moribund infants for whom withdrawal of care being considered.
13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures.
14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \[eg, Grade 3 or 4\] intracranial hemorrhage).

Where this trial is running

Little Rock, Arkansas and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypoxic-Ischemic EncephalopathyBirth AsphyxiaAnoxic brain injury
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.