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NCT05778188 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hypoxic Ischemic Encephalopathy, sponsored by ReAlta Life Sciences.

Recruiting
Registry status
Phase 2
Development phase
42
Enrollment target
15
Study locations

NCT05778188 is a Phase 2 study of Hypoxic Ischemic Encephalopathy that is actively recruiting participants, run by ReAlta Life Sciences. The registered enrollment target is 42 participants, below the 80-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (47% lower). The trial reports 15 study locations across 11 states.

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The verdict

NCT05778188, a Phase 2 study of Hypoxic Ischemic Encephalopathy, is actively recruiting participants, sponsored by ReAlta Life Sciences.

RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
15
Study locations

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

Conditions Studied

Hypoxic Ischemic Encephalopathy

Interventions

  • DRUG Placebo
  • DRUG RLS-0071

Study Locations (15)

California

  • Study Site 013 - Orange
  • Study Site 020 - San Diego
  • Study Site 019 - San Diego

Florida

  • Study Site 001 - Gainesville
  • Study Site 018 - Miami
  • Study Site 010 - Orlando

Arkansas

  • Study Site 016 - Little Rock

Indiana

  • Study Site 014 - Indianapolis

Kentucky

  • Study Site 012 - Lexington

Massachusetts

  • Study Site 002 - Boston

Missouri

  • Study Site 006 - St Louis

North Carolina

  • Study Site 003 - Durham

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2023-07-27
Est. Completion 2026-04
Phase Phase 2

Sponsor

ReAlta Life Sciences

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05778188

The ClinicalTrials.gov registry entry for NCT05778188 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (47% lower). The listed sponsor is ReAlta Life Sciences, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05778188 reports 15 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05778188 about?

NCT05778188 is a clinical study titled "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". 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...

What is the current status of trial NCT05778188?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2023-07-27. Estimated completion is 2026-04.

What conditions does trial NCT05778188 study?

This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy.

What interventions are being tested in trial NCT05778188?

The interventions under investigation include: Placebo (DRUG), RLS-0071 (DRUG).

Who is sponsoring clinical trial NCT05778188?

This trial is sponsored by ReAlta Life Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05778188 being conducted?

This trial has 15 study locations across Arkansas, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.