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 range4 Days – 5 Days
SexALL
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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.
What they're measuring
1
Frequency of adverse events
Timeframe: Day 1 to 36 weeks PMA(post menstrual age)