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.
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Clinical Trial Information
Trial Contact: Martinez, Helen L; Kube, Alicia
Trial Phone: 3218434472 ; 321.841.7485
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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
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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.
