A Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants with Necrotizing Enterocolitis.

A Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants with Necrotizing Enterocolitis.

  • Clinical Trial Information

    Trial Contact: Martinez, Helen L; Kube, Alicia; Kern, Katelyn D; Spinelli, Jennifer

  • IRB No: 24.038.02

    Protocol Abbrev: ST266-NEC-201

    Principal Investigator: Michael R Gomez, MD

    Phase: Drug: Phase I

    Age Group: Neonate

    ClinicalTrials.gov ID: NCT06315738

  • Objective

    To determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via intravenous (IV) route of administration of ST266 in treating patients with Bell’s stage IIA or higher NEC.