Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Primary Purpose
Intestinal Malabsorption
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ELGN-2112
Placebo
Sponsored by
About this trial
This is an interventional other trial for Intestinal Malabsorption
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ELGN-2112 Human insulin [rDNA]
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05904626
Brief Title
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elgan Pharma Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Malabsorption
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELGN-2112 Human insulin [rDNA]
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ELGN-2112
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
Primary Outcome Measure Information:
Title
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
Description
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Time Frame
Five days from birth until 42 days
Title
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
Description
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Time Frame
Five days from birth until 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Olshansky
Phone
972-4-6098626
Email
CA@elganpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miki Olshansky
Organizational Affiliation
Elgan Pharma Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
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