RecruitingPhase 2NCT05904626

Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA


Sponsor

Elgan Pharma Ltd.

Enrollment

60 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.


Eligibility

Min Age: 1 DayMax Age: 5 Days

Inclusion Criteria3

  • Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
  • Birth weight ≥ 450g
  • Singleton or twin birth

Exclusion Criteria1

  • N/A

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Interventions

DRUGELGN-2112

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.

DRUGPlacebo

A placebo formulation consisting of the same inactive ingredients as ELGN-2112.


Locations(1)

Laniado Hospital

Netanya, Israel

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NCT05904626


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