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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• ≥ 36 weeks gestation.

• 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.

• Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):

‣ 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 \[CPAP\]).

⁃ 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).

• Be eligible to receive therapeutic hypothermia.

• Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).

• Product of a singleton pregnancy.

• Written informed consent obtained from parent or legal guardian.

Locations
United States
Arkansas
Study Site 016
RECRUITING
Little Rock
California
Study Site 013
RECRUITING
Orange
Study Site 019
RECRUITING
San Diego
Study Site 020
RECRUITING
San Diego
Florida
Study Site 001
RECRUITING
Gainesville
Study Site 018
RECRUITING
Miami
Study Site 010
RECRUITING
Orlando
Indiana
Study Site 014
RECRUITING
Indianapolis
Kentucky
Study Site 012
WITHDRAWN
Lexington
Massachusetts
Study Site 002
RECRUITING
Boston
Missouri
Study Site 006
RECRUITING
St Louis
North Carolina
Study Site 003
RECRUITING
Durham
Ohio
Study Site 021
RECRUITING
Cleveland
Texas
Study Site 022
RECRUITING
Fort Worth
West Virginia
Study Site 005
ACTIVE_NOT_RECRUITING
Morgantown
Contact Information
Primary
Dawn Buchanan
dbuchanan@realtals.com
757-901-0457
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2026-04
Participants
Target number of participants: 42
Treatments
Experimental: RLS-0071
Doses of RLS-0071 to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours.
Placebo_comparator: Placebo
Doses of sterile saline (sodium chloride, 0.9%) to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours.
Related Therapeutic Areas
Sponsors
Collaborators: Premier Research
Leads: ReAlta Life Sciences, Inc.

This content was sourced from clinicaltrials.gov