protocolSection identificationModule nctId: NCT06350838, orgStudyIdInfo id: KN-BCG-I, briefTitle: Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2023-02-13, completionDateStruct date: 2023-02-13, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Chengdu CoenBiotech Co., Ltd, class: INDUSTRY, collaborators name: Hunan Cancer Hospital, descriptionModule briefSummary: Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC), conditionsModule conditions: Non-muscular Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: BCG for Therapeutic Use, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events;, primaryOutcomes measure: Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT)., primaryOutcomes measure: Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count., primaryOutcomes measure: Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT)., primaryOutcomes measure: Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count., primaryOutcomes measure: Effects on vital signs,such as temperature., primaryOutcomes measure: Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram., primaryOutcomes measure: Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure., primaryOutcomes measure: Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function., secondaryOutcomes measure: Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG)., secondaryOutcomes measure: Shedding condition of the test drug in urine., secondaryOutcomes measure: To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 415000, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False