[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FELIQS INC.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100600112","phase-1-safety-pk-and-pd-of-flq-101-in-premature-neonates-100600112",false,"NCT07093255","Safety, PK and PD of FLQ-101 in Premature Neonates","A Phase 1b, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of FLQ-101 in Premature Neonates at High Risk of Developing ROP","tROPhy-1","Inclusion Criteria:\n\n* Written consent is obtained from parent(s) or legal guardian.\n* Neonates born at 26 weeks +0 days and 27 weeks +6 days of gestation.\n* Male or female infants with a birth weight greater than or equal to 650 gm.\n\nExclusion Criteria:\n\n* Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures.\n* Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities.\n* Neonates who are seriously ill and not expected to survive.\n* 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).\n* Neonates that are small for gestational age defined as having a weight \\\u003C10th percentile at birth based on the Fenton growth charts for gestational age and sex.\n* 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.\n* 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.\n* Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.","ALL","4 Days","5 Days",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.",[28],"Retinopathy of Prematurity (ROP)","RECRUITING","2026-04-16",{"date":32,"type":33},"2026-04-21","ACTUAL",{"date":35,"type":33},"2026-04-03",{"date":37,"type":22},"2026-12-31",{"name":39,"class":40},"FELIQS INC.","INDUSTRY",""]