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

Intestinal Malabsorption Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05904626
• Other study ID #: FIT-05
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: Elgan Pharma Ltd.
• Contact: Miki Olshansky
• Phone: 972-4-6098626
• Email: CA[@]elganpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Malabsorption
• Malabsorption Syndromes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elgan Pharma Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five days from birth until 42 days
Primary	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.	Five days from birth until 42 days