[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588709":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":59,"studyPopulation":48,"armGroups":60,"interventions":118,"overallOfficials":128,"centralContacts":133,"locations":138,"responsibleParty":352,"collaborators":48,"id":354,"slug":355,"hasResults":356,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":48,"eligibilityCriteria":360,"healthyVolunteers":361,"sex":362,"minAge":363,"maxAge":364,"enrollmentInfo":365,"targetDuration":48,"studyType":368,"phases":369,"briefSummary":371,"conditions":372,"keywords":48,"overallStatus":141,"whyStopped":48,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},{"fullName":5,"class":6},"Bambusa Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":48},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Number of participants with adverse events following single and multiple administration of BBT002","Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.","Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration",{"measure":14,"description":15,"timeFrame":12},"Number of participants with change in Laboratory assessments","Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis",{"measure":17,"description":18,"timeFrame":12},"Number of participants with change in vital sign measurements following dose administration.","Blood pressure and heart rate will be assessed.",{"measure":20,"description":21,"timeFrame":12},"Number of participants with change in physical examination following dose administration.","Physical examination will be assessed.",{"measure":23,"description":24,"timeFrame":12},"Number of participants with change in 12-lead ECG readings","12-lead ECG will be assessed.",[26,30,33,36,39,42,45],{"measure":27,"description":28,"timeFrame":29},"PK parameters- maximum observed concentration (Cmax)","Maximum observed concentration of the study drug in serum will be analyzed for all subjects","At specified timepoints pre-dose and up to 169 days post first dose administration",{"measure":31,"description":32,"timeFrame":29},"PK parameters- Time of maximum observed Concentration (Tmax)","Serum PK Tmax will be analyzed for all subjects",{"measure":34,"description":35,"timeFrame":29},"PK parameters- Area under the curve (AUC)","Area under the curve of the study drug in serum will be analyzed for all subjects",{"measure":37,"description":38,"timeFrame":29},"PK parameters- Volume of distribution (Vz)","Volume of distribution of the study drug in serum will be analyzed for all subjects",{"measure":40,"description":41,"timeFrame":29},"PK parameters- Total clearance (CL)","Total clearance of the study drug in serum will be analyzed for all subjects",{"measure":43,"description":44,"timeFrame":29},"PK parameters- - Elimination Half-life (t1\u002F2).","Elimination half-life of the study drug in serum will be analyzed for all subjects",{"measure":46,"description":47,"timeFrame":29},"The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).","Serum Anti-Drug Antibodies will be analyzed for all subjects",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"TRIPLE",[56,57,58],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.",[61,67,71,75,81,85,89,93,97,100,103,107,111,115],{"label":62,"type":63,"description":64,"interventionNames":65},"Part A: BBT002","EXPERIMENTAL","A single dose of BBT002 will be administered in healthy volunteers",[66],"Drug: BBT002",{"label":68,"type":63,"description":69,"interventionNames":70},"Part B: BBT002","Multiple doses of BBT002 will be administered in healthy volunteers.",[66],{"label":72,"type":63,"description":73,"interventionNames":74},"Part C: BBT002","Multiple doses of BBT002 will be administered in patients with COPD",[66],{"label":76,"type":77,"description":78,"interventionNames":79},"Part A: Placebo","PLACEBO_COMPARATOR","A single dose of Placebo will be administered in healthy volunteers.",[80],"Drug: Placebo",{"label":82,"type":77,"description":83,"interventionNames":84},"Part B: Placebo","Multiple doses of Placebo will be administered in healthy volunteers.",[80],{"label":86,"type":77,"description":87,"interventionNames":88},"Part C: Placebo","Multiple doses of Placebo will be administered in patients with COPD.",[80],{"label":90,"type":77,"description":91,"interventionNames":92},"Part D: Placebo","Multiple doses of Placebo will be administered in patients with CRSwNP.",[80],{"label":94,"type":77,"description":95,"interventionNames":96},"Part E: Placebo","Single dose of Placebo will be administered in healthy volunteers.",[80],{"label":98,"type":77,"description":87,"interventionNames":99},"Part F: Placebo",[80],{"label":101,"type":77,"description":91,"interventionNames":102},"Part G: Placebo",[80],{"label":104,"type":63,"description":105,"interventionNames":106},"Part D: BBT002","Multiple doses of BBT002 will be administered in patients with CRSwNP.",[66],{"label":108,"type":63,"description":109,"interventionNames":110},"Part E: BBT002","Single dose of BBT002 will be administered in healthy volunteers.",[66],{"label":112,"type":63,"description":113,"interventionNames":114},"Part F: BBT002","Multiple doses of BBT002 will be administered in patients with COPD.",[66],{"label":116,"type":63,"description":105,"interventionNames":117},"Part G: BBT002",[66],[119,124],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":48},"DRUG","BBT002","BBT002 will be administered.",[62,68,72,104,108,112,116],{"type":120,"name":125,"description":126,"armGroupLabels":127,"otherNames":48},"Placebo","Placebo will be administered.",[76,82,86,90,94,98,101],[129],{"name":130,"affiliation":131,"role":132},"Tracy Ji","Bambusa Therapeutics, Inc.","STUDY_DIRECTOR",[134],{"name":130,"role":135,"phone":136,"phoneExt":48,"email":137},"CONTACT","+86 18001322760","Tracy.Ji@bambusatx.com",[139,160,177,191,208,223,240,252,262,274,292,306,320,337],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"Equity Medical Bowling Green","RECRUITING","Bowling Green","Kentucky","42104","United States","US",{"type":148,"coordinates":149},"Point",[150,151],-86.4436,36.99032,{"lat":151,"lon":150},[154,158],{"name":155,"role":135,"phone":156,"phoneExt":48,"email":157},"Dr. James Allred","844-378-9633","Jallred@equity-med.com",{"name":155,"role":159,"phone":48,"phoneExt":48,"email":48},"PRINCIPAL_INVESTIGATOR",{"facility":161,"status":162,"city":163,"state":143,"zip":164,"country":145,"countryCode":146,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Equity Medical - Owensboro","NOT_YET_RECRUITING","Owensboro","42303",{"type":148,"coordinates":166},[167,168],-87.11333,37.77422,{"lat":168,"lon":167},[171,176],{"name":172,"role":135,"phone":173,"phoneExt":174,"email":175},"Dr. David Johnsonn","270-426-9184","457","djohnson@equity-med.com",{"name":172,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":178,"status":141,"city":179,"state":179,"zip":180,"country":145,"countryCode":146,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Equity Medical LLC","New York","10023",{"type":148,"coordinates":182},[183,184],-74.00597,40.71427,{"lat":184,"lon":183},[187,190],{"name":188,"role":135,"phone":156,"phoneExt":48,"email":189},"Dr. Monalyn Zousias","Mzouzias@equity-med.com",{"name":188,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":192,"status":141,"city":193,"state":194,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Linear Clinical Research","Perth","Western Australia","6009","Australia","AU",{"type":148,"coordinates":199},[200,201],115.8614,-31.95224,{"lat":201,"lon":200},[204,206],{"name":205,"role":135,"phone":48,"phoneExt":48,"email":48},"Lara Hatchuel, Dr",{"name":207,"role":159,"phone":48,"phoneExt":48,"email":48},"Dr. Lara Hatchuel",{"facility":209,"status":141,"city":210,"state":48,"zip":211,"country":196,"countryCode":197,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Momentum Clinical Research","Brisbane","4068",{"type":148,"coordinates":213},[214,215],153.02809,-27.46794,{"lat":215,"lon":214},[218,222],{"name":219,"role":135,"phone":220,"phoneExt":48,"email":221},"Dr Xin Yi (Ellie) Ngoh","0732785255","Ellie.Ngoh@momentumclinicalresearch.com.au",{"name":219,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":224,"status":141,"city":225,"state":48,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Aleksandre Aladashvili Clinic LLC","Tbilisi","0198","Georgia","GE",{"type":148,"coordinates":230},[231,232],44.83412,41.69143,{"lat":232,"lon":231},[235,239],{"name":236,"role":135,"phone":237,"phoneExt":48,"email":238},"Dr. Sopiko Kruashvili","+995598530083","Sophiekruashvili@gmail.com",{"name":236,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":241,"status":141,"city":225,"state":48,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":242,"geoPoint":244,"contacts":245},"Geo Hospitals Tbilisi Multiprofile Medical Center",{"type":148,"coordinates":243},[231,232],{"lat":232,"lon":231},[246,250],{"name":247,"role":135,"phone":248,"phoneExt":48,"email":249},"Dr. Elene Khurtsidze","+995574747574","ekhurtsidze@gh.ge",{"name":251,"role":159,"phone":48,"phoneExt":48,"email":48},"Elene Khurtsidze",{"facility":253,"status":141,"city":225,"state":48,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":254,"geoPoint":256,"contacts":257},"LEPL The First University Clinic of Tbilisi State Medical University",{"type":148,"coordinates":255},[231,232],{"lat":232,"lon":231},[258,261],{"name":259,"role":135,"phone":48,"phoneExt":48,"email":260},"Dr. Shorena Khazaradze","shorenakhazaradze01@gmail.com",{"name":259,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":263,"status":141,"city":225,"state":48,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Ltd Aversi Clinic",{"type":148,"coordinates":265},[231,232],{"lat":232,"lon":231},[268,272],{"name":269,"role":135,"phone":270,"phoneExt":48,"email":271},"Dr. David Tchkonia","+995577785575","David.tchkonia@gmail.com",{"name":273,"role":159,"phone":48,"phoneExt":48,"email":48},"David Tchkonia",{"facility":275,"status":162,"city":276,"state":277,"zip":278,"country":279,"countryCode":280,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Momentum Clinical Research Hamilton","Rotorua","Hamilton","3010","New Zealand","NZ",{"type":148,"coordinates":282},[283,284],176.24516,-38.13874,{"lat":284,"lon":283},[287,291],{"name":288,"role":135,"phone":289,"phoneExt":48,"email":290},"Dr Victoria Siriett","0273415595","Victoria@clinicaltrialswaikato.co.nz",{"name":288,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":209,"status":141,"city":293,"state":48,"zip":294,"country":279,"countryCode":280,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Pukekohe","2120",{"type":148,"coordinates":296},[297,298],174.90363,-37.20196,{"lat":298,"lon":297},[301,305],{"name":302,"role":135,"phone":303,"phoneExt":48,"email":304},"Dr Michelle Baker","+640508919919","Michelle.baker@momentumclinicalresearch.co.nz",{"name":302,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":209,"status":141,"city":307,"state":48,"zip":308,"country":279,"countryCode":280,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Wellington","6021",{"type":148,"coordinates":310},[311,312],174.77557,-41.28664,{"lat":312,"lon":311},[315,319],{"name":316,"role":135,"phone":317,"phoneExt":48,"email":318},"Dr Dean Quinn","+6448010002","dean@p3research.co.nz",{"name":316,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":321,"status":162,"city":322,"state":48,"zip":323,"country":324,"countryCode":325,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz","Gdansk","80-214","Poland","PL",{"type":148,"coordinates":327},[328,329],18.64912,54.35227,{"lat":329,"lon":328},[332,336],{"name":333,"role":135,"phone":334,"phoneExt":48,"email":335},"Iwona Damps-Konstanska","+48 535575210","katarzyna.swietnicka@gmail.com",{"name":333,"role":159,"phone":48,"phoneExt":48,"email":48},{"facility":338,"status":162,"city":339,"state":48,"zip":340,"country":324,"countryCode":325,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.","Krakow","31-011",{"type":148,"coordinates":342},[343,344],19.93658,50.06143,{"lat":344,"lon":343},[347,351],{"name":348,"role":135,"phone":349,"phoneExt":48,"email":350},"Katarzyna Gajda","48690000367","katarzyna.gajda@dobrylekarz.com.pl",{"name":348,"role":159,"phone":48,"phoneExt":48,"email":48},{"type":353,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100588709","phase-1-a-study-of-bbt002-in-healthy-volunteers-hvs-and-in-adult-patients-with-chronic-obstructive-pulmonary-disease-copd-or-chronic-rhiosininusitis-with-nasal-polyps-crswnp-100588709",false,"NCT06944925","A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)","A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients With COPD or CRSwNP","Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)\n\n1. Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)\n2. Body mass index between 18.0-32.0 kg\u002Fm square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg\u002Fm square, capped weight at 125kg for patients (Parts C, D, F, and G)\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 C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second\u002FForced Vital Capacity less than 0.70\n\nKey Inclusion Criteria (Parts D and G)\n\n1\\. Participants with confirmed diagnosis of CRSwNP\n\nKey Exclusion Criteria for (Parts A, B, C, D, E, F, and G)\n\n1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)\n2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections\n3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders\n4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function\n5. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1\n6. Abnormal Electrocardiogram(ECG) findings\n7. History of drug\u002Falcohol abuse in the past 2 years\n8. History of severe allergic reactions or hypersensitivity\n\nKey Exclusion Criteria (Part C and F only)\n\n1. Current diagnosis of other significant pulmonary disease\n2. Significant or unstable cardiovascular diseases\n3. Recent clinically significant infection\n4. Inability to perform spirometry\n\nKey Exclusion Criteria (Parts D and G)\n\n1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP\n2. Sinonasal surgery (recent\u002Fextensiv)\n3. Consitions interfering with nasal assessments\n4. Excluded sinonasal\u002Fsystemic diseases",true,"ALL","18 Years","80 Years",{"count":366,"type":367},286,"ESTIMATED","INTERVENTIONAL",[370],"PHASE1","Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).",[373],"Chronic Obstructive Pulmonary Disease","2026-06-28",{"date":376,"type":377},"2026-07-01","ACTUAL",{"date":379,"type":377},"2025-05-08",{"date":381,"type":367},"2027-07-31",{"name":5,"class":6},14]