[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613285":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":43,"centralContacts":44,"locations":50,"responsibleParty":64,"collaborators":43,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":43,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":43,"enrollmentInfo":75,"targetDuration":43,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":87,"whyStopped":43,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1~ Dose Level 4","PLACEBO_COMPARATOR","dose level 1、dose level 2、dose level 3、dose level 4",[13,14],"Drug: GS3-007a dry suspension","Drug: Placebo for GS3-007a dry suspension",{"label":16,"type":17,"description":18,"interventionNames":19},"Cohort 1~ Cohort 3","ACTIVE_COMPARATOR","GS3-007a low dose , GS3-007a high dose , rhGH 0.033mg\u002Fkg",[13,20],"Drug: rhGH injection",{"label":22,"type":23,"description":24,"interventionNames":25},"GS3-007a cohort","EXPERIMENTAL","GS3-007a optimal dose",[13],[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","GS3-007a dry suspension","GS3-007a",[16,9,22],[30],{"type":28,"name":34,"description":34,"armGroupLabels":35,"otherNames":36},"Placebo for GS3-007a dry suspension",[9],[37],"placebo",{"type":28,"name":39,"description":39,"armGroupLabels":40,"otherNames":41},"rhGH injection",[16],[42],"rhGH",null,[45],{"name":46,"role":47,"phone":48,"phoneExt":43,"email":49},"Lingli Sun, bachelor","CONTACT","+86 18006171657","sunlingli@genscigroup.com",[51],{"facility":52,"status":43,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":43},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology","Wuhan","Hubei","430000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],114.26667,30.58333,{"lat":62,"lon":61},{"type":65,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100613285","phase-1-a-study-phase-1b2-of-gs3-007a-oral-treatment-in-children-with-growth-hormone-deficiency-pghd-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":76,"type":77},88,"ESTIMATED","INTERVENTIONAL",[80,81],"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.",[84],"Pediatric Growth Hormone Deficiency",[29,86],"PGHD","NOT_YET_RECRUITING","2025-11-24",{"date":90,"type":91},"2025-12-04","ACTUAL",{"date":93,"type":77},"2025-12",{"date":95,"type":77},"2030-11",{"name":5,"class":6},1]