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Clinical trial

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

NCT05778188 is registered in ClinicalTrials.gov with ReAlta Life Sciences, Inc. as lead sponsor.

NCT NCT05778188
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
ReAlta Life Sciences, Inc.
Phase
Phase 2
Overall status
Recruiting
Start date
July 27, 2023
Completion date
December 31, 2028
Enrollment
70 (estimated)
Sites
15

Conditions

As the registry lists them; a condition with its own page is linked.

hypoxic-ischemic encephalopathy