Safety, PK and PD of FLQ-101 in Premature Neonates (NCT07093255) | Clinical Trial Compass
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
United States18 participantsStarted 2026-04-03
Plain-language summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Who can participate
Age range
4 Days – 5 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily measuring how often adverse events occur, what does that mean for what is and isn't yet known about whether FLQ-101 is safe for premature newborns?
2Given that my baby is a premature neonate, what are the specific risks involved in participating in an early-phase drug trial at this stage of development, compared to the standard treatments currently available for retinopathy of prematurity?
3What does the PK and PD part of this study mean in plain terms — is the main goal to understand how FLQ-101 moves through and affects a premature baby's body, rather than to prove it treats ROP?
4What are the current standard-of-care options for retinopathy of prematurity, and would pursuing those first affect our ability to consider this trial later if needed?
5What would participation actually involve for my baby day-to-day — how many visits, what procedures, and how would that affect our care routine in the NICU or after discharge?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of adverse events
Timeframe: Day 1 to 36 weeks PMA(post menstrual age)