[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613285":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":65,"overallOfficials":11,"centralContacts":82,"locations":88,"responsibleParty":102,"collaborators":11,"id":104,"slug":11,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":11,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":11,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":124,"whyStopped":11,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Treatment Emergent Adverse Events (TEAEs)",null,"up to 21 days (Ib phase)",{"measure":14,"description":11,"timeFrame":15},"Annualized height velocity (AHV) at Week 26 of treatment","26 weeks (II phase)",{"measure":17,"description":11,"timeFrame":18},"Number of Participants With TEAEs","up to 160 weeks (II phase extension)",[20,23,26,29,32,34],{"measure":21,"description":11,"timeFrame":22},"PK concentrations of GS3-007a and metabolite GS3-017","up to 7 days (Ib phase)",{"measure":24,"description":11,"timeFrame":25},"Concentrations of serum growth hormone (GH), insulin-like growth factor-1 (IGF-1), and insulin-like growth factor-binding protein 3 (IGFBP-3)","up to 14 days (Ib phase)",{"measure":27,"description":11,"timeFrame":28},"AHVs at each evaluation point","13 weeks, 39 weeks, 52 weeks (II phase)",{"measure":30,"description":11,"timeFrame":31},"Changes from baseline (ΔIGF-1 SDS) in the standard deviation score of the PD indicator insulin-like growth factor-1 (IGF-1 SDS) at each evaluation point","4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks (II phase)",{"measure":27,"description":11,"timeFrame":33},"up to 156 weeks (II phase extension)",{"measure":35,"description":11,"timeFrame":33},"Change from extension baseline in the height standard deviation score at each evaluation point (ΔHT SDS)",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":42},"TRIPLE",[43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[47,54,60],{"label":48,"type":49,"description":50,"interventionNames":51},"Dose Level 1~ Dose Level 4","PLACEBO_COMPARATOR","dose level 1、dose level 2、dose level 3、dose level 4",[52,53],"Drug: GS3-007a dry suspension","Drug: Placebo for GS3-007a dry suspension",{"label":55,"type":56,"description":57,"interventionNames":58},"Cohort 1~ Cohort 3","ACTIVE_COMPARATOR","GS3-007a low dose , GS3-007a high dose , rhGH 0.033mg\u002Fkg",[52,59],"Drug: rhGH injection",{"label":61,"type":62,"description":63,"interventionNames":64},"GS3-007a cohort","EXPERIMENTAL","GS3-007a optimal dose",[52],[66,72,77],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","GS3-007a dry suspension","GS3-007a",[55,48,61],[69],{"type":67,"name":73,"description":73,"armGroupLabels":74,"otherNames":75},"Placebo for GS3-007a dry suspension",[48],[76],"placebo",{"type":67,"name":78,"description":78,"armGroupLabels":79,"otherNames":80},"rhGH injection",[55],[81],"rhGH",[83],{"name":84,"role":85,"phone":86,"phoneExt":11,"email":87},"Lingli Sun, bachelor","CONTACT","+86 18006171657","sunlingli@genscigroup.com",[89],{"facility":90,"status":11,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":11},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology","Wuhan","Hubei","430000","China","CN",{"type":97,"coordinates":98},"Point",[99,100],114.26667,30.58333,{"lat":100,"lon":99},{"type":103,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100613285",false,"NCT07264595","A Study (Phase 1b\u002F2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)","A Study to Evaluate the Safety and Tolerability of Multiple Ascending Doses of GS3-007a Dry Suspension in Patients With PGHD and to Evaluate the Efficacy and Safety of 52-week of Treatment With GS3-007a Dry Suspension: a Two-part, Multicenter, Randomized, Phase Ib\u002FII Clinical Trial","Inclusion Criteria:\n\n* chronological age (CA) ≥3 years at Screening\n* Prepubertal girls or boys\n* Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD)\n* A confirmed diagnosis of growth hormone deficiency (GHD)\n* Having not been treated with any growth-promoting drugs\n* BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period)\n* Subjects who have completed the 52-week treatment period of phase II\n* Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II\n\nExclusion Criteria:\n\n* A highly allergic constitution\n* Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH\n* Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth\n* Congenital skeletal dysplasia or serious spinal anomalies\n* Cognitive hypofunction, neurodevelopmental disorders, or psychiatric\u002Fpsychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth\n* Concurrent use of any medications that may affect growth or response to growth hormone therapy\n* Epiphyseal closure\n* Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT\u002FQTc interval prolonged\n* Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period)\n* Subjects with closed epiphyses\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Known or suspected allergy to the IMP\n* Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit","ALL","3 Years",{"count":113,"type":114},88,"ESTIMATED","INTERVENTIONAL",[117,118],"PHASE1","PHASE2","This is a two-part clinical study for children with growth hormone deficiency. In the first part, participants will be randomly assigned to receive different doses of an oral treatment (GS3-007a dry suspension) or a placebo for 14 days. This part is double-blinded, meaning neither the participants nor the doctors will know who is receiving the treatment or placebo. The goal is to find a safe and well-tolerated dose.\n\nIn the second part, participants will be randomly assigned to receive either the selected dose of GS3-007a or another approved treatment for 52 weeks. This part is open-label, so everyone will know which treatment is being given. After that, all participants may continue taking GS3-007a for another 156 weeks in an extension phase to study long-term effects.",[121],"Pediatric Growth Hormone Deficiency",[68,123],"PGHD","NOT_YET_RECRUITING","2025-11-24",{"date":127,"type":128},"2025-12-04","ACTUAL",{"date":130,"type":114},"2025-12",{"date":132,"type":114},"2030-11",{"name":5,"class":6},1]