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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. David's Medical Center
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Office
• Email: clinicaltrial@feliqs.com
• Phone: +81-942-707-330

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.