Status: Recruiting
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.
Participants needed: 36
Trial details
Phase: Phase 1, Phase 2Age: 2-8Biological sex: AllType: InterventionalSponsor: Noveome Biotherapeutics, formerly StemnionUpdated: Apr 13, 2026Locations: 8
Eligibility criteria
Infants born from ≥22 weeks gestational age up to and including 40 weeks gestati... [+1]
Infants with abdominal perforation. [+15]