[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539886":3},{"organization":4,"armGroups":7,"interventions":53,"overallOfficials":64,"centralContacts":59,"locations":69,"responsibleParty":82,"collaborators":59,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":59,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":59,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":59,"overallStatus":105,"whyStopped":59,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"ProGen. Co., Ltd.","OTHER",[8,15,19,23,27,31,35,39,42,46,50],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1 - Single Ascending Dose","EXPERIMENTAL","PG-102(MG12) Dose 1 (N=8) Subcutaneous injection",[13,14],"Drug: PG-102(MG12)","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort A2 - Single Ascending Dose","PG-102(MG12) Dose 2 (N=8) Subcutaneous injection",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort A3 - Single Ascending Dose","PG-102(MG12) Dose 3 (N=8) Subcutaneous injection",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort A4 - Single Ascending Dose","PG-102(MG12) Dose 4 (N=8) Subcutaneous injection",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Cohort A5 - Multiple Ascending Dose","PG-102(MG12) Dose 5 (N=8) Subcutaneous injection",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort B1 - Multiple Ascending Dose","PG-102(MG12) Dose 1 (N=6) Subcutaneous injection",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort B2 - Multiple Ascending Dose","PG-102(MG12) Dose 1\\~5 (N=6) Subcutaneous injection",[13,14],{"label":40,"type":10,"description":37,"interventionNames":41},"Cohort B3 - Multiple Ascending Dose",[13,14],{"label":43,"type":10,"description":44,"interventionNames":45},"Cohort S - Multiple Ascending Dose","PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection",[13,14],{"label":47,"type":10,"description":48,"interventionNames":49},"Cohort C1 - Multiple Ascending Dose","PG-102(MG12) Dose 1 (N=12) Subcutaneous injection",[13,14],{"label":51,"type":10,"description":48,"interventionNames":52},"Cohort C2 - Multiple Ascending Dose",[13,14],[54,60],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","PG-102(MG12)","GLP-1 and GLP-2 fusion protein",[9,16,20,24,28,32,36,40,47,51,43],null,{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":59},"Placebo","Placebo drug of PG-102(MG12)",[9,16,20,24,28,32,36,40,47,51,43],[65],{"name":66,"affiliation":67,"role":68},"Seunghoon Han, MD","Catholic University Seoul St.Mary Hospital","PRINCIPAL_INVESTIGATOR",[70],{"facility":71,"status":59,"city":72,"state":73,"zip":74,"country":75,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":81,"contacts":59},"Catholic University Seoul St.Mary Hospital,","Seocho","Seoul","06591","South Korea",{"type":77,"coordinates":78},"Point",[79,80],127.02,37.49056,{"lat":80,"lon":79},{"type":83,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100539886","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-and-pharmacodynamics-following-subcutaneous-injections-of-pg-102-mg12-in-healthy-adult-and-obesity-participants-100539886",false,"NCT06309667","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.","A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants","Inclusion Criteria:\n\n1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent\n2. Body mass index (BMI) of 18 to 30kg\u002Fm2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg\u002Fm2 (inclusive) for Part B and Body mass index (BMI) 30 kg\u002Fm² or higher for Part C\n\n\\[Exclusion Criteria\\]\n\n1. History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and\u002For other foods within 90 days prior to screening:\n\n   * Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods\u002Fsupplements, and formulas designed for weight control).\n   * Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.\n2. History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.\n3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and\u002For severe neuropathy.\n4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).",true,"ALL","19 Years","65 Years",{"count":96,"type":97},102,"ACTUAL","INTERVENTIONAL",[100],"PHASE1","This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.\n\nThis study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.",[103,104],"Healthy","Overweight","COMPLETED","2025-05-05",{"date":108,"type":97},"2025-05-06",{"date":110,"type":97},"2024-03-04",{"date":112,"type":97},"2025-02-05",{"name":5,"class":6},1]