RecruitingPhase 1NCT07093255

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

A Phase 1b, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of FLQ-101 in Premature Neonates at High Risk of Developing ROP

Sponsor

FELIQS INC.

Enrollment

18 participants

Start Date

Apr 3, 2026

Study Type

INTERVENTIONAL

Conditions

Retinopathy of Prematurity (ROP)

Summary

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

Eligibility

Min Age: 4 DaysMax Age: 5 Days

Inclusion Criteria3

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 Criteria8

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.