Safety, PK and PD of FLQ-101 in Premature Neonates

The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.

Inclusion Criteria: * Written consent is obtained from parent(s) or legal guardian. * Neonates born at 26 weeks +0 days and 27 weeks +6 days of gestation. * Male or female infants with a birth weight greater than or equal to 650 gm. Exclusion Criteria: * Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures. * Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities. * Neonates who are seriously ill and not expected to survive. * Neonates with heart disease, including cardiomyopathy, serious arrhythmias, and congenital heart disease. (Neonates with patent foramen ovale may be included in the study if clinically stable). * Neonates that are small for gestational age defined as having a weight \<10th percentile at birth based on the Fenton growth charts for gestational age and sex. * Neonates with history of or ongoing intraventricular hemorrhage (IVH) grades 2, 3 or 4. Neonates with IVH grade 1 may be included in the study at the discretion of the PI. * Neonates with any other medical conditions or clinically significant comorbidities or circumstances that in the opinion of the investigator may have a relevant impact on study participation or any of the study assessments or procedures. * Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.