[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564903":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":11,"studyPopulation":11,"armGroups":64,"interventions":80,"overallOfficials":11,"centralContacts":90,"locations":96,"responsibleParty":113,"collaborators":115,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":11,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":11,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"IlDong Pharmaceutical Co Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"AEs\u002Fserious AEs (SAEs)",null,"Throughout study duration, up to 47 days",[14,18,20,22,24,26,28,30,32,35,39,41,43,45,49,51],{"measure":15,"description":16,"timeFrame":17},"Maximum concentration of drug in plasma (Cmax)","To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.","Day 1 and Day 28",{"measure":19,"description":16,"timeFrame":17},"Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)",{"measure":21,"description":16,"timeFrame":17},"The time of peak concentration (Tmax)",{"measure":23,"description":16,"timeFrame":17},"Terminal half-life (t1\u002F2)",{"measure":25,"description":16,"timeFrame":17},"Apparent clearance (CL\u002FF)",{"measure":27,"description":16,"timeFrame":17},"Apparent volume of distribution after extravascular administration (Vd\u002FF)",{"measure":29,"description":16,"timeFrame":17},"Renal clearance (CLR)",{"measure":31,"description":16,"timeFrame":17},"fe",{"measure":33,"description":16,"timeFrame":34},"Trough plasma concentration taken directly before the next dose (Ctrough)","Throughout study duration, up to 27 days",{"measure":36,"description":37,"timeFrame":38},"Minimum concentration of drug in plasma at steady state (Cmin, ss)","To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.","Day 28",{"measure":40,"description":37,"timeFrame":38},"Average concentration of drug in plasma at steady state (Cavg, ss)",{"measure":42,"description":37,"timeFrame":38},"peak to trough fluctuation (PTF)",{"measure":44,"description":37,"timeFrame":38},"accumulation ratio (R)",{"measure":46,"description":47,"timeFrame":48},"Serum glucose","To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.","up to 28 days",{"measure":50,"description":47,"timeFrame":48},"Insulin",{"measure":52,"description":53,"timeFrame":54},"Hemoglobin A1c (HbA1c)","To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.","up to 47 days",{"allocation":56,"interventionModel":57,"interventionModelDescription":11,"primaryPurpose":58,"observationalModel":11,"timePerspective":11,"maskingInfo":59},"RANDOMIZED","SEQUENTIAL","BASIC_SCIENCE",{"masking":60,"maskingDescription":11,"whoMasked":61},"DOUBLE",[62,63],"PARTICIPANT","INVESTIGATOR",[65,72,76],{"label":66,"type":67,"description":68,"interventionNames":69},"Cohort 1","EXPERIMENTAL","Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)",[70,71],"Drug: ID110521156","Drug: Placebo of 110521156",{"label":73,"type":67,"description":74,"interventionNames":75},"Cohort 2","Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)",[70,71],{"label":77,"type":67,"description":78,"interventionNames":79},"Cohort 3","Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)",[70,71],[81,86],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"DRUG","ID110521156","ID110521156 capsules taken orally once daily",[66,73,77],{"type":82,"name":87,"description":88,"armGroupLabels":89,"otherNames":11},"Placebo of 110521156","ID110521156 placebo capsules taken orally once daily",[66,73,77],[91],{"name":92,"role":93,"phone":94,"phoneExt":11,"email":95},"Clinical Ops Study Leader","CONTACT","+82-10-4570-1405","eh.hong@yunovia.com",[97],{"facility":98,"status":99,"city":100,"state":11,"zip":101,"country":102,"countryCode":11,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Seoul National University Hospital","RECRUITING","Seoul","03080","South Korea",{"type":104,"coordinates":105},"Point",[106,107],126.9784,37.566,{"lat":107,"lon":106},[110],{"name":111,"role":93,"phone":112,"phoneExt":11,"email":11},"Seunghwan Lee","+82-2-741-4221",{"type":114,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[116],{"name":117,"class":118},"YUNOVIA CO.,LTD.","UNKNOWN","100564903","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-id110521156-in-healthy-adult-subjects-100564903",false,"NCT06635226","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects","A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy subjects aged 19 to 50 years at the time of Screening.\n* Body mass index (BMI) within ≥27 kg\u002Fm2; and a total body weight ≥ 50 kg\n* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study\n* For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.\n* Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.\n* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.",true,"ALL","19 Years","50 Years",{"count":131,"type":132},36,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.",[138],"Healthy Adult Subjects","2024-12-19",{"date":141,"type":142},"2024-12-24","ACTUAL",{"date":144,"type":142},"2024-11-13",{"date":146,"type":132},"2025-06-19",{"name":5,"class":6},1]