Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Sponsor
Elgan Pharma Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05904626
Collaborator
(none)
60
2
24
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Anticipated Study Start Date
:
Sep 1, 2023
Anticipated Primary Completion Date
:
Sep 1, 2025
Anticipated Study Completion Date
:
Sep 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ELGN-2112 Human insulin [rDNA]
|
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 Comparator: Placebo
|
Drug: Placebo
A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
|
Outcome Measures
Primary Outcome Measures
- Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA [Five days from birth until 42 days]
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. [Five days from birth until 42 days]
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 5 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Elgan Pharma Ltd.
Investigators
- Study Director: Miki Olshansky, Elgan Pharma Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Elgan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT05904626
Other Study ID Numbers:
- FIT-05
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: