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
This trial does not accept healthy volunteersQualifiers
Written consent is obtained from parent(s) or legal guardian.
Neonates born at 25 weeks +0 days and 27 weeks +6 days of gestation.
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
Design model
Single group
Treatments tested in this trial
FLQ-101
DrugThe invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: FLQ-101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of adverse events
Time frame
Day 1 to 36 weeks PMA(post menstrual age)Secondary outcomes
1
Pharmacokinetic parameters of FLQ-101
Time frame
Day 1 to 24 hours post first oral dose2
Pharmacodynamic parameters of FLQ-101
Time frame
Day 1 to 24 hours post first oral doseSponsors and contacts
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Source ClinicalTrials.gov