Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Description

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.

Conditions

Necrotizing Enterocolitis

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Study Overview

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Study Details

Study overview

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.

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

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Condition
Necrotizing Enterocolitis
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies, Orlando, Florida, United States, 32806

Tampa

BayCare Health System-St. Joseph's Women's Hospital, Tampa, Florida, United States, 33607

Evanston

NorthShore University-Evanston Hospital, Evanston, Illinois, United States, 60201

Durham

Duke University Medical Center (DUMC), Durham, North Carolina, United States, 27710

Oklahoma City

Oklahoma Children's Hospital, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Premature (≥26 and ≤36 weeks gestational age) infant weight between ≥800g and ≤3000g. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
  • 2. Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.
  • 1. Infants with abdominal perforation at less than 10 days of life
  • 2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care.
  • 3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
  • 4. Mother's receipt of any investigational product during pregnancy.
  • 5. Infants with malignancies.
  • 6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
  • 7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
  • 8. Infants with anatomic defects that require surgical intervention.
  • 9. Infants with persistent pulmonary hypertension of newborn.
  • 10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
  • 11. Infants who have hypoxic ischemic injury (perinatal asphyxia).
  • 12. Infants with polycythemia (at time of treatment) (\>22 g/dL).
  • 13. Positive maternal human immunodeficiency virus status.
  • 14. History of maternal drug abuse.
  • 15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Ages Eligible for Study

2 Weeks to 8 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Noveome Biotherapeutics, formerly Stemnion,

Study Record Dates

2029-11