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

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.