Intestinal Malabsorption
Conditions
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.
Interventions
DRUGELGN-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.
DRUGPlacebo
A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
Sponsors
Elgan Pharma Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Contacts
CONTACTMiki Olshansky
STUDY_DIRECTORMiki Olshansky
Elgan Pharma Ltd.
Outcome results
None listed