[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bambusa Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,64,89,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100578221","phase-1-a-study-of-bbt001-in-healthy-volunteers-hvs-and-in-adult-patients-with-atopic-dermatitis-ad-100578221",false,"NCT06808477","A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With 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 Patients","Key Inclusion Criteria (Part A, B, C, D)\n\n1. Age of 18-65 years.\n2. Body mass index between 18-32 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 (Parts C and E 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.\n\nKey Exclusion Criteria for (Part A, B, C, D)\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 (Parts C and E 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":21,"type":22},198,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).",[28],"Atopic Dermatitis","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2025-02-27",{"date":37,"type":22},"2027-02-06",{"name":39,"class":40},"Bambusa Therapeutics","INDUSTRY",7,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"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","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","80 Years",{"count":51,"type":22},286,[25],"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).",[55],"Chronic Obstructive Pulmonary Disease","2026-06-28",{"date":32,"type":33},{"date":59,"type":33},"2025-05-08",{"date":61,"type":22},"2027-07-31",{"name":39,"class":40},14,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100626539","phase-1-a-study-of-bbt002-in-healthy-volunteers-hvs-and-in-patients-with-chronic-rhinosinusitis-with-nasal-polyps-crswnp-and-comorbid-asthma-100626539","NCT07436949","A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma","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 Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma","Inclusion Criteria: Part (A\\&B):\n\n1. Age of 18-55 years (HVs), 18-75 years (patients)\n2. Body mass index between 18-30 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\n\nKey Inclusion Criteria (Part B only)\n\n1. Participants with physician-diagnosed CRSwNP for at least 12 months prior to randomization\n2. SNOT-22 total score ≥30 at screening and randomization.\n3. Documented systemic corticosteroid use (or contraindication\u002Fintolerance) within past 24 months.\n4. Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.\n\nExclusion Criteria:Part (A\\&B):\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 for (Part B only):\n\n1. Any sinus\u002Fnasal surgery (including polypectomy) within 6 months before screening, History of ≥2 prior sinus\u002Fnasal surgeries\n2. Concurrent nasal conditions that may interfere with study assessments\n3. Significant or unstable cardiovascular diseases\n4. Recent clinically significant infection","75 Years",{"count":73,"type":22},64,[25,75],"PHASE2","This study is 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 Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma.",[78],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","NOT_YET_RECRUITING","2026-02-22",{"date":82,"type":33},"2026-02-27",{"date":84,"type":22},"2026-03-02",{"date":86,"type":22},"2027-05-30",{"name":39,"class":40},12,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":109},"100615126","phase-1-a-study-of-bbt002-in-healthy-volunteers-hvs-and-in-patients-with-chronic-obstructive-pulmonary-disease-copd-100615126","NCT07288554","A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)","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 Participants With Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:( A\\&B)\n\n1. Age of 18-65 years (HVs), 35-75 years (patients)\n2. Body mass index between 18-32 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. Documented history of COPD with a post-bronchodilator FEV1\u002FFVC \\\u003C 0.70\n2. FEV1 ≥ 50% and FEV1\\\u003C80% predicted at screening.\n\nExclusion Criteria:( part A \\& B)\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 for (Part B 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",{"count":97,"type":22},68,[25],"This study is 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 Participants with Chronic Obstructive Pulmonary Disease (COPD).",[101],"Chronic Obstructive Pulmonary Disease (COPD)","2026-01-04",{"date":104,"type":33},"2026-01-07",{"date":106,"type":33},"2025-09-05",{"date":86,"type":22},{"name":39,"class":40},11,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100611389","phase-1-a-study-of-bbt001-in-healthy-volunteers-hvs-and-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-ad-100611389","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.",{"count":118,"type":22},63,[25],"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).",[28],"2025-11-16",{"date":124,"type":33},"2025-11-20",{"date":126,"type":33},"2025-08-09",{"date":128,"type":22},"2027-03-26",{"name":39,"class":40},10,""]