Safety, PK and PD of FLQ-101 in Premature Neonates
Recruiting now · Phase 1
Conditions studied: Retinopathy of Prematurity (ROP)
In brief
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Key facts
- Study ID
- NCT07093255
- Run by
- FELIQS INC.
- People needed
- 18
- Starts
- 2026-04-03
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-21
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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 is running
- St. David's Medical Center — Austin, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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