Safety, PK and PD of FLQ-101 in Premature Neonates (tROPhy-1)

FELIQS INC.

Status and phase

Not yet enrolling

Phase 1

Conditions

Retinopathy of Prematurity (ROP)

Treatments

Drug: FLQ-101

Study type

Interventional

Funder types

Industry

Identifiers

FLQCT-01

Details and patient eligibility

About

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

Enrollment

18 estimated patients

Sex

All

Ages

4 to 5 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.