Retinopathy of Prematurity (ROP)
Conditions
Brief summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Interventions
DRUGFLQ-101
The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Sponsors
FELIQS INC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Days to 5 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events | Day 1 to 36 weeks PMA(post menstrual age) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of FLQ-101 | Day 1 to 24 hours post first oral dose |
| Pharmacodynamic parameters of FLQ-101 | Day 1 to 24 hours post first oral dose |
Countries
United States
Contacts
CONTACTClinical Trial Office
Outcome results
None listed