[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611389":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":43,"locations":48,"responsibleParty":204,"collaborators":33,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":33,"eligibilityCriteria":212,"healthyVolunteers":213,"sex":214,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":33,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":33,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},{"fullName":5,"class":6},"Bambusa Therapeutics","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A -BBT001(Single Ascending Dose)","EXPERIMENTAL","A single dose of BBT001 will be administered in healthy volunteers",[13],"Drug: BBT001",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A- Placebo(Single Ascending Dose)","A single dose of Placebo will be administered in healthy volunteers",[18],"Drug: Placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"Part B- BBT001(Multiple Ascending Dose)","Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Part B -Placebo (Multiple Ascending Dose))","Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis",[18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","BBT001","BBT001 will be administered",[9,20],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo","Placebo will be administered",[15,24],[39],{"name":40,"affiliation":41,"role":42},"Tracy Ji","Bambusa (Beijing) Therapeutics Co., 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College","NOT_YET_RECRUITING","Wuhu","241001",{"type":58,"coordinates":77},[78,79],118.42947,31.35259,{"lat":79,"lon":78},[82],{"name":83,"role":45,"phone":84,"phoneExt":33,"email":85},"Ruzhi Zhang, Principle Investigator","0553-2871846","zhangruzhi628@163.com",{"facility":87,"status":73,"city":88,"state":89,"zip":90,"country":55,"countryCode":56,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Peking University People's Hospital","Beijing","Beijing Municipality","100032",{"type":58,"coordinates":92},[93,94],116.39723,39.9075,{"lat":94,"lon":93},[97],{"name":98,"role":45,"phone":99,"phoneExt":33,"email":100},"Jianzhong Zhang, Principle Investigator","010-88324516","rmzjz@126.com",{"facility":102,"status":73,"city":103,"state":104,"zip":105,"country":55,"countryCode":56,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Dermatology Hospital of Southern Medical University","Guangzhou","Guangdong","510440",{"type":58,"coordinates":107},[108,109],113.25,23.11667,{"lat":109,"lon":108},[112],{"name":113,"role":45,"phone":114,"phoneExt":33,"email":115},"Bin Yang, Principle Investigator","020-8306 8888","yangbin101@hotmail.com",{"facility":117,"status":73,"city":118,"state":119,"zip":120,"country":55,"countryCode":56,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"The Second Xiangya Hospital of Central South University","Changsha","Hunan","410011",{"type":58,"coordinates":122},[123,124],112.97087,28.19874,{"lat":124,"lon":123},[127],{"name":128,"role":45,"phone":84,"phoneExt":33,"email":129},"Yunsheng Liang, Principle Investigator","yunshenglianggcp@163.com",{"facility":131,"status":73,"city":132,"state":133,"zip":134,"country":55,"countryCode":56,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Wuxi Second People's Hospital","Wuxi","Jiangsu","214002",{"type":58,"coordinates":136},[137,138],120.28857,31.56887,{"lat":138,"lon":137},[141],{"name":142,"role":45,"phone":143,"phoneExt":33,"email":144},"Xiaoli Zhang, Principle Investigator","0510-68562222","zxl415@163.com",{"facility":146,"status":73,"city":147,"state":133,"zip":148,"country":55,"countryCode":56,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Jiangsu University Affiliated Hospital","Zhenjiang","212001",{"type":58,"coordinates":150},[151,152],119.45508,32.21086,{"lat":152,"lon":151},[155],{"name":156,"role":45,"phone":157,"phoneExt":33,"email":158},"Yumei Li, Principle Investigator","0511-85026832","l.yumei@aliyun.com",{"facility":160,"status":73,"city":161,"state":162,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Jiangxi Provincial Dermatology Hospital","Nanchang","Jiangxi","330000",{"type":58,"coordinates":165},[166,167],115.85306,28.68396,{"lat":167,"lon":166},[170],{"name":171,"role":45,"phone":172,"phoneExt":33,"email":173},"Guohong Hu, Principle Investigator","0791-85214720","20079850@qq.com",{"facility":175,"status":73,"city":176,"state":177,"zip":178,"country":55,"countryCode":56,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Shandong Provincial Hospital for Skin Diseases","Jinan","Shandong","250011",{"type":58,"coordinates":180},[181,182],116.99722,36.66833,{"lat":182,"lon":181},[185],{"name":186,"role":45,"phone":187,"phoneExt":33,"email":188},"Furen Zhang, Principle Investigator","0531-87298882","zhangfuren@hotmail.com",{"facility":190,"status":73,"city":191,"state":192,"zip":193,"country":55,"countryCode":56,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Shanghai Dermatology Hospital","Shanghai","Shanghai Municipality","200050",{"type":58,"coordinates":195},[196,197],121.45806,31.22222,{"lat":197,"lon":196},[200],{"name":201,"role":45,"phone":202,"phoneExt":33,"email":203},"Yangfeng Ding","021-61833000","dingyangfeng@aliyun.com",{"type":205,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100611389","phase-1-a-study-of-bbt001-in-healthy-volunteers-hvs-and-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-ad-100611389",false,"NCT07239947","A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)","A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient","Key Inclusion Criteria ( Part A and B):\n\n1. Age of 18-65 years.\n2. Body mass index between 18-28 kg\u002Fm², capped at 120 kg.\n3. Negative pregnancy tests for women of childbearing potential.\n4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.\n5. Non-smokers, healthy current smokers (≤5 cigarettes\u002Fday), or ex-smokers.\n6. Adequate contraception use (for men and women of childbearing potential).\n7. No clinically significant abnormalities or history of relevant diseases.\n\nKey Inclusion Criteria (Part B only):\n\n1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.\n2. Moderate to severe atopic dermatitis\n3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3\n4. Atopic lesions cover ≥10% of body surface area (BSA)\n5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.\n6. Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.\n\nKey Exclusion Criteria for (Part A\\&B)\n\n1. Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.\n2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.\n3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.\n4. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1.\n5. Abnormal Electrocardiogram (ECG) findings\n6. History of drug\u002Falcohol abuse in the past 2 years.\n7. Donated \\>500mL blood within 2 months of screening.\n8. History of severe allergic reactions or hypersensitivity.\n\nKey Exclusion Criteria for (Part B only)\n\n1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.\n2. Receipt of immunoglobulin or blood products within 30 days.\n3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.\n4. Chronic pruritus from conditions other than atopic dermatitis.\n5. Acute\u002Ftreated infections or chronic skin infections.\n6. Current use of sedating antihistamines or corticosteroids.",true,"ALL","18 Years","65 Years",{"count":218,"type":219},63,"ESTIMATED","INTERVENTIONAL",[222],"PHASE1","This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).",[225],"Atopic Dermatitis","2025-11-16",{"date":228,"type":229},"2025-11-20","ACTUAL",{"date":231,"type":229},"2025-08-09",{"date":233,"type":219},"2027-03-26",{"name":5,"class":6},10]