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

Phase 2Not Yet RecruitingNCT05904626

Elgan Pharma Ltd.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Intestinal Malabsorption

Interventions

ELGN-2112DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 5 Days

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: N/A

Outcomes

Primary Outcomes

Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA

Safety will be assessed by capturing of adverse events (AEs) during the treatment period.

Time frame: Five days from birth until 42 days

Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.

Safety will be assessed by capturing of adverse events (AEs) during the treatment period.

Time frame: Five days from birth until 42 days

Central Contacts

Miki Olshansky

CONTACT

972-4-6098626 CA@elganpharma.com

Data from ClinicalTrials.gov

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