Testing FLQ-101 for retinopathy of prematurity in very premature newborns

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

This will test whether giving FLQ-101 to very premature babies (born at 26+0 to 27+6 weeks and weighing ≥650 g) is safe and produces the expected drug effects in their bodies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 4 Days to 5 Days
• Sex: All
• Sponsor: FELIQS INC. (industry)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07093255 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional study focused on safety, pharmacokinetics (PK), and pharmacodynamics (PD) of FLQ-101 after exposure in very premature neonates at risk for retinopathy of prematurity. Eligible infants are those born at 26+0 to 27+6 weeks' gestation with birth weight ≥650 g and whose parents provide written consent, while infants with major congenital anomalies, ocular malformations, severe infections, or who are not expected to survive are excluded. Participants will receive FLQ-101 according to the protocol and undergo clinical monitoring, ocular assessments, and blood sampling to characterize drug levels and biological effects. The study is conducted at a single site and is designed to detect safety signals and define PK/PD parameters rather than to prove clinical efficacy.

Who should consider this trial

Good fit: Ideal candidates are neonates born at 26+0 to 27+6 weeks' gestation with a birth weight of at least 650 g whose parents or legal guardians provide written consent and who do not meet exclusion criteria.

Not a fit: Infants with major congenital or ocular malformations, severe congenital infection, chromosomal abnormalities, small-for-gestational-age status (<10th percentile), significant heart disease, or who are unlikely to survive are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, FLQ-101 could offer a new and safer treatment approach that reduces the risk or severity of retinopathy of prematurity in very preterm infants.

How similar studies have performed: Some treatments for ROP, such as anti-VEGF injections and laser therapy, have shown benefit, but PK/PD and safety data for new systemic or ocular agents specifically in extremely preterm neonates remain limited, so this approach is early and relatively untested in this population.

Eligibility criteria

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.

Where this trial is running

Austin, Texas

• St. David's Medical Center — Austin, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Clinical Trial Office

Conditions: Retinopathy of Prematurity