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FLQ-101 for Retinopathy of Prematurity (ROP) in Premature Neonates

This study is looking at a drug called FLQ-101 to see if it is safe and effective for premature babies with Retinopathy of Prematurity (ROP). ROP is an eye condition that can affect babies born too early. We are testing three different dose levels of FLQ-101. To join, babies must be born between 26 and 27 weeks of pregnancy, weigh at least 650 grams at birth, and be between 4 and 5 days old. We are looking for 18 babies to participate. The main goal is to track any side effects from the drug up to 36 weeks after the baby's expected due date. The current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 18 premature neonates into three different dose groups of FLQ-101.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to track adverse events (side effects) from Day 1 up to 36 weeks post menstrual age (PMA).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07093255

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

Recruiting
PHASE1Ages 4–5InterventionalPrevention
FELIQS INC.
~18 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:FLQ-101

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of adverse events
Measured over Day 1 to 36 weeks PMA(post menstrual age)

Conditions

Retinopathy of Prematurity (ROP)

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Retinopathy of Prematurity

NCT07093255

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • St. David's Medical Center

    Austin, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clinical Trial Office
[email protected]
+81-942-707-330
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Frequency of adverse eventsDay 1 to 36 weeks PMA(post menstrual age)