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Recruiting Phase 1

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

NCT07093255 · tracked via the Priya Life Science USA tracker
Sponsor
FELIQS INC
Phase
Phase 1
Started
2026-04-03
Last updated
2026-10-13

Condition(s) studied

Retinopathy of Prematurity (ROP)

Investigational drug(s) / intervention(s)

FLQ-101

FLQ-101: The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose

Study summary

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

Eligibility

Sex
ALL
Min age
4 Days
Max age
5 Days
Healthy volunteers
No
Inclusion Criteria: * Written consent is obtained from parent(s) or legal guardian. * Neonates born at 25 weeks +0 days and 27 weeks +6 days of gestation. 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.

Primary outcome measure(s)

  • Frequency of adverse events — Day 1 to 36 weeks PMA(post menstrual age)

Trial sites (1)

FacilityCityRegionStatus
St. David's Medical Center Austin Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093255 on ClinicalTrials.gov ↗ ← All trials in the USA