NCT05778188 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions

Hypoxic-Ischemic Encephalopathy

Interventions

DRUG

RLS-0071

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.

DRUG

Placebo

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.

Trial Locations (15)

26506

RECRUITING

Study Site 005, Morgantown

27710

RECRUITING

Study Site 003, Durham

32608

RECRUITING

Study Site 001, Gainesville

32803

RECRUITING

Study Site 010, Orlando

33143

RECRUITING

Study Site 018, Miami

40536

WITHDRAWN

Study Site 012, Lexington

44195

RECRUITING

Study Site 021, Cleveland

46202

RECRUITING

Study Site 014, Indianapolis

63110

RECRUITING

Study Site 006, St Louis

72202

RECRUITING

Study Site 016, Little Rock

76104

RECRUITING

Study Site 022, Fort Worth

92037

RECRUITING

Study Site 020, San Diego

92123

RECRUITING

Study Site 019, San Diego

92868

RECRUITING

Study Site 013, Orange

02115

RECRUITING

Study Site 002, Boston