Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT05818306
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase Ia Safety and Tolerability Study of BL-001
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Both the Investigator and the subjects are not aware of the treatment administered.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety \\& tolerability Phase Ia study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-26', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of BL-001', 'timeFrame': 'Treatment-emergent adverse events are reviewed from screening through Day 28', 'description': 'Safety and tolerability of BL-001 as measured by treatment-emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Intestinal engraftment', 'timeFrame': 'Fecal samples are collected by the subjects at home from screening through Day 28', 'description': 'The intestinal engraftment of the microbiota with BL-001 component strains'}, {'measure': 'Intestinal microbiota changes', 'timeFrame': 'Fecal samples are collected by the subjects at home from screening through Day 28', 'description': 'Changes in the intestinal microbiota, including microbial taxonomic and functional characterization as well as diversity metrics'}, {'measure': 'Metabolite changes in stool samples', 'timeFrame': 'Fecal samples are collected by the subjects at home from screening through Day 28', 'description': 'Analysis of metabolite changes in stool samples'}, {'measure': 'Metabolite changes in plasma samples', 'timeFrame': 'Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28', 'description': 'Analysis of metabolite changes in plasma samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bloom Science', 'Bloom', 'BL-001', 'Microbiome', 'LBP', 'Live Biological Product', 'Live Biotherapeutic Product'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.', 'detailedDescription': 'This is a Phase 1a randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose study to evaluate the safety and tolerability of BL-001.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion criteria\n\n1. Informed consent: signed written informed consent before inclusion in the study\n2. Sex and Age: men/women, 18-55 years old inclusive\n3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive\n4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position\n5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study\n6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the protocol defined and reliable methods of contraception\n\nKey Exclusion criteria\n\n1. Electrocardiogram 12-leads (supine position): clinically significant abnormalities\n2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study\n3. Bowel movements: on average ≥3 stools per day or \\<3 stools per week\n4. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness\n5. Allergy: ascertained or presumptive hypersensitivity to the formulation's ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study\n6. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study\n7. Gastrointestinal: evidence of acute or chronic gastrointestinal disorders\n8. Medications and probiotics: probiotics, nutraceuticals, and medications, including over the counter medications and herbal remedies for 2 weeks and antibiotics for 3 months before the start of the study. Hormonal contraceptives for women will be allowed"}, 'identificationModule': {'nctId': 'NCT05818306', 'briefTitle': 'A Phase Ia Safety and Tolerability Study of BL-001', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bloom Science'}, 'officialTitle': 'A Phase Ia, Randomized, Parallel-group, Double-blind, Placebo-controlled, Single-center, Multiple Dose Safety and Tolerability Study of Ascending Doses of BL-001 Oral Capsules Administered for 28 Days to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BL-001-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A Dose 1', 'description': 'Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)', 'interventionNames': ['Drug: BL-001', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B Dose 2', 'description': 'Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)', 'interventionNames': ['Drug: BL-001', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C Dose 3', 'description': 'Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)', 'interventionNames': ['Drug: BL-001', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D Dose 4', 'description': 'Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)', 'interventionNames': ['Drug: BL-001', 'Drug: Placebo']}], 'interventions': [{'name': 'BL-001', 'type': 'DRUG', 'description': 'Live biological product BL-001', 'armGroupLabels': ['Cohort A Dose 1', 'Cohort B Dose 2', 'Cohort C Dose 3', 'Cohort D Dose 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Cohort A Dose 1', 'Cohort B Dose 2', 'Cohort C Dose 3', 'Cohort D Dose 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6864', 'city': 'Arzo', 'state': 'Canton Ticino', 'country': 'Switzerland', 'facility': 'CROSS Research S.A.', 'geoPoint': {'lat': 45.87606, 'lon': 8.94103}}], 'overallOfficials': [{'name': 'Paolo Baroldi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bloom Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bloom Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}