This clinical trial is focused on studying the safety of a treatment called ELGN-2112 in infants with a condition known as Intestinal Malabsorption. Intestinal Malabsorption is a condition where the intestines cannot absorb nutrients properly. The treatment being tested is an oral solution containing Insulin Human, which is a protein that helps regulate blood sugar levels. The study will compare the effects of ELGN-2112 to a placebo in preterm infants born before 26 weeks of gestation and infants with Intra-Uterine Growth Restriction (IUGR), which means they are smaller than expected for their gestational age.

The purpose of the study is to assess the safety of ELGN-2112 in these specific groups of infants. Participants in the study will receive either the treatment or a placebo, and their health will be monitored over a period of time. The study will look at various factors, such as how long it takes for the infants to achieve full feeding through the intestines, the occurrence of a serious intestinal condition called Necrotizing Enterocolitis (NEC), and the number of days until they can be discharged from the hospital. The study will also track other health outcomes, including the incidence of infections and the infants’ growth and development.

This trial is designed to provide important information about the safety of ELGN-2112 in helping infants with Intestinal Malabsorption and related conditions. By participating in this study, researchers hope to better understand how this treatment can support the health and development of these vulnerable infants.