[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615563":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":43,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":34,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":34,"overallStatus":46,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"BGM1812(Part A)","EXPERIMENTAL","Single ascending doses of BGM1812 administered subcutaneously (SC)",[13],"Drug: BGM1812",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Part A)","PLACEBO_COMPARATOR","Placebo administered SC",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"BGM1812 (Part B)","Multiple ascending doses of BGM1812 administered SC.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Placebo (Part B)","Placebo administered SC.",[19],[29,35,39,41],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","BGM1812","AdministeredSC",[9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Administered SC",[15],{"type":30,"name":31,"description":37,"armGroupLabels":40,"otherNames":34},[21],{"type":30,"name":36,"description":37,"armGroupLabels":42,"otherNames":34},[25],[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The First Affiliated Hospital of Yunnan University of Chinese Medicine","RECRUITING","Kunming","Yunnan","650000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],102.71833,25.03889,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":62,"phoneExt":34,"email":63},"Jianchang He","CONTACT","13700680697","hejc@yn-cprc.com",{"type":65,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[67],{"name":68,"class":69},"BrightGene Pharmaceutical Co., Ltd.","UNKNOWN","100615563","phase-1-a-study-of-bgm1812-injection-in-healthy-and-non-diabetic-overweight-or-obese-chinese-participants-100615563",false,"NCT07294235","A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single\u002FMultiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants","Inclusion Criteria:\n\n* Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;\n* Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg\u002Fm² ≤ BMI \\\u003C 24 kg\u002Fm²（BMI = weight\u002Fheight²）;\n* Obese individuals: BMI ≥ 28.0 kg\u002Fm², or overweight individuals: 24.0 kg\u002Fm² ≤ BMI \\\u003C 28.0 kg\u002Fm²;\n* (Medical Inquiry) Have a stable body weight (\\\u003C5% self-reported change during the previous 12 weeks) before screening.\n* Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.\n* Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose.\n\nExclusion Criteria:\n\n* Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases\u002Fhistory, or with a severe allergic constitution.\n* Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.\n* 12-lead ECG shows ventricular heart rate \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin at screening\u002Fbaseline, second or third degree atrioventricular block, long QT syndrome, QTcF\\> 470ms for women or \\> 450ms for men, pre-excitation syndrome or other significant arrhythmias.\n* Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.\n* Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.\n* Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.\n* Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.\n* Positive urine drug test or alcohol serum test result at screening or at baseline.\n* Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.",true,"ALL","18 Years","55 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.",[89],"Overweight or Obesity","2025-12-07",{"date":92,"type":93},"2025-12-19","ACTUAL",{"date":95,"type":93},"2025-12-05",{"date":97,"type":83},"2026-03-02",{"name":5,"class":6},1]