Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02540460
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627008', 'term': 'delpazolid'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No of Adverse events', 'timeFrame': 'From date of randomization until follow up after 3 days from last hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Cmax(Peak plasma concentration)', 'timeFrame': '0(predose), 0.5, 1, 2, 4, 8 and 12hours', 'description': 'Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days'}, {'measure': 'Pharmacokinetics: AUC(Area under the curve)', 'timeFrame': '0(predose), 0.5, 1, 2, 4, 8 and 12hours', 'description': 'Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29069400', 'type': 'DERIVED', 'citation': 'Choi Y, Lee SW, Kim A, Jang K, Nam H, Cho YL, Yu KS, Jang IJ, Chung JY. Safety, tolerability and pharmacokinetics of 21 day multiple oral administration of a new oxazolidinone antibiotic, LCB01-0371, in healthy male subjects. J Antimicrob Chemother. 2018 Jan 1;73(1):183-190. doi: 10.1093/jac/dkx367.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.\n\nTo investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.', 'detailedDescription': 'Double blind, randomized, placebo control, multiple dose, dose escalation study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male between 20 and 45 years of age at the time of screening\n2. Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening\n3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion\n4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n1. History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)\n2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)\n3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics\n4. History of drug abuse or positive result at urine drug screening\n5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN"}, 'identificationModule': {'nctId': 'NCT02540460', 'briefTitle': 'Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371', 'organization': {'class': 'INDUSTRY', 'fullName': 'LigaChem Biosciences, Inc.'}, 'officialTitle': 'A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LCB01-0371-14-1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCB01-0371 800mg', 'description': 'LCB01-0371 800mg', 'interventionNames': ['Drug: LCB01-0371 800mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LCB01-0371 800mg BID', 'description': 'LCB01-0371 800mg BID', 'interventionNames': ['Drug: LCB01-0371 800mg BID', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LCB01-0371 1200mg BID', 'description': 'LCB01-0371 1200mg BID', 'interventionNames': ['Drug: LCB01-0371 1200mg BID', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LCB01-0371 800mg', 'type': 'DRUG', 'description': 'LCB01-0371 800mg', 'armGroupLabels': ['LCB01-0371 800mg']}, {'name': 'LCB01-0371 800mg BID', 'type': 'DRUG', 'description': 'LCB01-0371 800mg BID', 'armGroupLabels': ['LCB01-0371 800mg BID']}, {'name': 'LCB01-0371 1200mg BID', 'type': 'DRUG', 'description': 'LCB01-0371 1200mg BID', 'armGroupLabels': ['LCB01-0371 1200mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['LCB01-0371 1200mg BID', 'LCB01-0371 800mg', 'LCB01-0371 800mg BID', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bundang', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital'}], 'overallOfficials': [{'name': 'Young Lag Cho, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Legochembioscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LigaChem Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}