NCT05904626

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Elgan Pharma Ltd. · Industry
• Sex: All
• Age: 1 Day – 5 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Intestinal Malabsorption

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	A placebo formulation consisting of the same inactive ingredients as ELGN-2112.

Timeline

• Start date: 2025-10-28
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-06-15
• Last updated: 2026-04-09

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study