Clinical Trials in the USA / NCT07093255
Recruiting
Phase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
NCT07093255 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Retinopathy of Prematurity (ROP)
Investigational drug(s) / intervention(s)
FLQ-101
FLQ-101: The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Study summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Eligibility
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.
Primary outcome measure(s)
- Frequency of adverse events — Day 1 to 36 weeks PMA(post menstrual age)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| St. David's Medical Center | Austin | Texas | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07093255 on ClinicalTrials.gov ↗ ← All trials in the USA