Actively Recruiting
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
Led by FELIQS INC. · Updated on 2026-04-21
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of FLQ-101 in premature newborns who are at high risk of developing retinopathy of prematurity (ROP). The study is a Phase 1b trial conducted by FELIQS INC. that focuses on understanding how the drug behaves in the body and its safety profile in this vulnerable population. Participants receive FLQ-101 in one of three dose groups: low, middle, or high dose. The trial includes a dose escalation design to carefully monitor responses to different amounts of the drug. The treatment period and assessments are structured to capture pharmacokinetic and pharmacodynamic data within 24 hours after the first oral dose. During the study, neonates will be closely observed from Day 1 until 36 weeks postmenstrual age for any adverse events. Researchers will measure drug levels and effects shortly after dosing. Safety and health assessments will be conducted regularly to ensure participant well-being. The total participation duration covers the critical early weeks of life for these premature infants to gather meaningful safety and drug behavior information.
CONDITIONS
Brief Title
Safety, PK and PD of FLQ-101 in Premature Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 1 to 36 weeks post menstrual age
Participants receive FLQ-101 at low, middle, or high dose to evaluate safety, pharmacokinetics, and pharmacodynamics.
Visits occur during treatment as per protocol assessments
Trial Site Locations
Total: 1 location
1
St. David's Medical Center
Austin, Texas, United States, 78705
Actively Recruiting
Research Team
C
Clinical Trial Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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