[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646835":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GenSci144 single-dose group.","EXPERIMENTAL",null,[13],"Drug: GenSci144 tablets",{"label":15,"type":16,"description":11,"interventionNames":17},"Matched placebo single-dose group.","PLACEBO_COMPARATOR",[18],"Drug: GenSci144 placebo tablets",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","GenSci144 tablets","SLC6A19 transporter small molecule inhibitor, oral tablets in 25mg and 75mg, given as a single dose on an empty stomach, used to explore treatment for phenylketonuria.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"GenSci144 placebo tablets","No active ingredients, appearance, excipients, and specifications are exactly the same as GenSci144.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Wei Zhao","CONTACT","+86 15131190710","zhao4wei2@hotmail.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Yanlin Chen","+86 18621909391","chenyanlin01@genscigroup.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).","RECRUITING","Jinan","Shandong","250014","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.99722,36.66833,{"lat":52,"lon":51},[55],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100646835","phase-1-gensci144-tablets-phase-i-clinical-trial-100646835",false,"NCT07685210","GenSci144 Tablets Phase I Clinical Trial","A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial in Healthy Adult Participants in China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of GenSci144","Inclusion Criteria:\n\n* Healthy men and women aged 18 to 45, with at least 3 people of the same gender in each group.\n* BMI 19\\~26 kg\u002Fm², men weigh ≥50 kg, women ≥45 kg.\n* Voluntarily sign the informed consent form, fully aware of the research risks and procedures.\n* Use reliable contraception for 3 months after the last dose, no plans for pregnancy or sperm\u002Fegg donation.\n\nExclusion Criteria:\n\n* A family history of sudden death and serious neuropsychiatric disorders.\n* Major underlying conditions like gastrointestinal absorption problems, chronic liver, kidney, heart, and endocrine diseases.\n* Liver function, kidney function with eGFR\\\u003C90, abnormal QTc interval, positive for various infectious diseases.\n* Drug allergies, drug abuse, recent participation in other clinical trials.\n* Drinking alcohol, smoking, taking grapefruit\u002Famino acid supplements, and having a chaotic routine during the screening period.\n* Pregnant or breastfeeding women, people who can't tolerate blood draws or get faint from needles.",true,"ALL","18 Years","45 Years",{"count":70,"type":71},48,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels. It was conducted using a randomized, double-blind, placebo-controlled design, primarily to evaluate the drug's safety and tolerability, while also exploring its pharmacokinetic and pharmacodynamic characteristics in the body, providing a basis for subsequent clinical use in the treatment of phenylketonuria.",[77],"Phenylketonuria","2026-06-30",{"date":80,"type":81},"2026-07-06","ACTUAL",{"date":83,"type":81},"2026-06-22",{"date":85,"type":71},"2026-12",{"name":5,"class":6},1]