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
Public ClinicalTrials.gov record NCT05778188. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up
Study identification
- NCT ID
- NCT05778188
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Industry
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- RLS-0071 Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 10 Hours
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 26, 2023
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2028
- Last update posted
- Apr 12, 2026
2023 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site 016 | Little Rock | Arkansas | 72202 | Recruiting |
| Study Site 013 | Orange | California | 92868 | Recruiting |
| Study Site 020 | San Diego | California | 92037 | Recruiting |
| Study Site 019 | San Diego | California | 92123 | Recruiting |
| Study Site 001 | Gainesville | Florida | 32608 | Recruiting |
| Study Site 018 | Miami | Florida | 33143 | Recruiting |
| Study Site 010 | Orlando | Florida | 32803 | Recruiting |
| Study Site 014 | Indianapolis | Indiana | 46202 | Recruiting |
| Study Site 012 | Lexington | Kentucky | 40536 | Withdrawn |
| Study Site 002 | Boston | Massachusetts | 02115 | Recruiting |
| Study Site 006 | St Louis | Missouri | 63110 | Recruiting |
| Study Site 003 | Durham | North Carolina | 27710 | Recruiting |
| Study Site 021 | Cleveland | Ohio | 44195 | Recruiting |
| Study Site 022 | Fort Worth | Texas | 76104 | Recruiting |
| Study Site 005 | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05778188, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05778188 live on ClinicalTrials.gov.