RecruitingPhase 3NCT05670951

Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants


Sponsor

Elgan Pharma Ltd.

Enrollment

360 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.


Eligibility

Min Age: 1 DayMax Age: 5 Days

Inclusion Criteria3

  • Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
  • Birth weight ≥ 500g
  • Singleton or twin birth

Exclusion Criteria1

  • \-

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Interventions

DRUGELGN-2112

Human insulin \[rDNA\]

DRUGPlacebo

Placebo


Locations(1)

Laniado Hospital

Netanya, Israel

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NCT05670951