Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) (NCT06315738)
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 (NEC)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arkansas Children's Hospital — Little Rock, Arkansas
Age range: 2 Weeks to 8 Weeks
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Arkansas Children's Hospital — Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Yale-New Haven Hospital — New Haven, Connecticut
- BayCare Health System-St. Joseph's Women's Hospital — Tampa, Florida
- NorthShore University-Evanston Hospital — Evanston, Illinois
- Oklahoma Children's Hospital — Oklahoma City, Oklahoma
- Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine — Hershey, Pennsylvania
- University of Pittsburgh Medical Center Magee Womens Hospital — Pittsburgh, Pennsylvania
📞 Contact the Study Coordinator
Phone: (412) 512-1446
Email: kpotoka@noveome.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Necrotizing Enterocolitis
- IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study — Tucson, Arizona
- Early Predictors of Necrotizing Enterocolitis in Neonates — Columbus, Ohio
- RIC-NEC Randomized Controlled Trial — Cincinnati, Ohio
- A Cohort Study of the Intestinal Microbiota of Premature Infants — Sacramento, California
- WithHolding Enteral Feeds Around Blood Transfusion (International) — Halifax, Nova Scotia
Explore by condition: All Necrotizing Enterocolitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.