[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600112":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"FELIQS INC.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FLQ-101","EXPERIMENTAL",null,[13],"Drug: FLQ-101",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","The invervention comprises 3 Groups:\n\n* Group 1: Low Dose\n* Group 2: Middle Dose\n* Group 3: High Dose",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Clinical Trial Office","CONTACT","+81-942-707-330","clinicaltrial@feliqs.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"St. David's Medical Center","RECRUITING","Austin","Texas","78705","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-97.74306,30.26715,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":11,"email":11},"Clininical Research Cordinator","512-544-8070",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":58,"type":59},18,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.",[65],"Retinopathy of Prematurity (ROP)","2026-04-16",{"date":68,"type":69},"2026-04-21","ACTUAL",{"date":71,"type":69},"2026-04-03",{"date":73,"type":59},"2026-12-31",{"name":5,"class":6},1]