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

Elgan Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Intestinal Malabsorption

Treatments: Drug: Placebo; Drug: ELGN-2112

Study type: Interventional

Funder types: Industry

Identifiers

NCT05904626

FIT-05

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 5 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

ELGN-2112 Human insulin [rDNA]

Active Comparator group

Treatment:

Drug: ELGN-2112

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo