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

Conditions

• Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

Sex

ALL

Age

N/A - 10 Hours

Healthy Volunteers

Not accepted

Interventions

• RLS-0071 — DRUG
  RLS-0071 (unit strength 10 mg/mL) will be administered by infusion for a dose level of 3 or 10 mg/kg. Planned infusion duration is 10 minutes for all dose levels.
• Placebo — DRUG
  Placebo control (commercial sterile saline) will be administered by infusion at a volume matched to RLS-0071 (3 or 10 mg/kg). Planned infusion duration is 10 minutes for all matched dose levels.

Study Details

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.

Key Dates

Start date

Jul 27, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14 [ Time Frame: Day 1 to Day 14 ]

Central Contacts

• Lori Upham
  757-901-0331
  [email protected]

Locations (15)

Find similar trials in Little Rock, AR

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