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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05670951