Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT03789734
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of BLS-M22 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in muscle mass after Administration', 'timeFrame': 'up to 4-5 weeks', 'description': 'Evaluation of the efficacy after Administraion of BLS-M22'}], 'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 4-5 weeks', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}], 'secondaryOutcomes': [{'measure': 'AUClast', 'timeFrame': 'From 0 hours to 24 hours', 'description': 'Evaluation of the pharmacokinetic properties after administration of BLS-M22'}, {'measure': 'Immunogenicity(Myostatin specific IgG level in serum)', 'timeFrame': 'up to 4-5 weeks', 'description': 'Evaluation of the immunogenicity after administration of BLS-M22'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscular Dystrophy, Duchenne']}, 'descriptionModule': {'briefSummary': 'BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm the safety of BLS-M22.', 'detailedDescription': 'This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22.\n\nThe single ascending dose group participated in 9 patients in each group(500mg, 1,000mg, 2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10 patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects between 19-55 years of age\n2. BMI: 19\\~28kg/m2(male), 18\\~25kg/m2(female) at screening test\n3. Able to provide consent to participate and having signed an Informed Consent Form (ICF)\n4. The subjects can obey the demands of the scheme\n\nExclusion Criteria:\n\n1. Subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system.\n2. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug\n3. Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization\n4. Subject has received steroids or other immunosuppressive drugs within 30 days of randomization\n5. Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis\n6. Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm\n7. Pregnant women\n8. Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n9. Subject has abnormal clinical laboratory test results\n10. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study'}, 'identificationModule': {'nctId': 'NCT03789734', 'briefTitle': 'Safety Study of BLS-M22 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioLeaders Corporation'}, 'officialTitle': 'A Dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22 Following Single/Multiple Oral Administration in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'BLS-M22-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLS-M22 or Placebo 500mg group', 'description': 'Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration', 'interventionNames': ['Biological: BLS-M22', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BLS-M22 or Placebo 1,000mg group', 'description': 'Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration', 'interventionNames': ['Biological: BLS-M22', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BLS-M22 or Placebo 2,000mg group', 'description': 'Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration', 'interventionNames': ['Biological: BLS-M22', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose group', 'description': 'Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration', 'interventionNames': ['Biological: BLS-M22', 'Other: Placebo']}], 'interventions': [{'name': 'BLS-M22', 'type': 'BIOLOGICAL', 'description': 'BLS-M22 250mg/capsule', 'armGroupLabels': ['BLS-M22 or Placebo 1,000mg group', 'BLS-M22 or Placebo 2,000mg group', 'BLS-M22 or Placebo 500mg group', 'Multiple Ascending Dose group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'BLS-M22 placebo 250mg/capsule', 'armGroupLabels': ['BLS-M22 or Placebo 1,000mg group', 'BLS-M22 or Placebo 2,000mg group', 'BLS-M22 or Placebo 500mg group', 'Multiple Ascending Dose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'state': 'Yongin-si', 'country': 'South Korea', 'facility': 'BioLeaders Co., Ltd.', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Doyoung Lee, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioLeaders corp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioLeaders Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}