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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.
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Day - 5 Days
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-28
Completion Date
2027-06
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
ELGN-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.
Placebo
A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
Locations (1)
Laniado Hospital
Netanya, Israel