Safety, PK and PD of FLQ-101 in Premature Neonates
ConditionRetinopathy of Prematurity (ROP)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-5
SponsorFELIQS INC.
About this trial
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- FLQ-101
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov