Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05058105
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events [Safety and Tolerability]', 'timeFrame': 'Day 1 to Day 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38054726', 'type': 'DERIVED', 'citation': 'Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adults aged between 18 and 45 years (inclusive).\n2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.\n3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.\n4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.\n\nExclusion Criteria:\n\n1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.\n2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.\n3. History of clinically significant food or drug allergy.\n4. A QT interval corrected using Fridericia's formula \\>450 msec.\n5. eGFR\\<90mL/min/1.73m2."}, 'identificationModule': {'nctId': 'NCT05058105', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'FL058-I-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FL058 500mg and Meropenem 1000mg', 'description': 'FL058 500mg and Meropenem 1000mg (8 subjects);\n\nFL058 Placebo and Meropenem 1000mg(2 subjects)', 'interventionNames': ['Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）', 'Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）']}, {'type': 'EXPERIMENTAL', 'label': 'FL058 1000mg and Meropenem 1000mg', 'description': 'D1\n\nFL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);\n\nD4\n\nMeropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);\n\nD7\\~ D15\n\nFL058 1000mg and Meropenem 1000mg (8 subjects);\n\nFL058 Placebo and Meropenem 1000mg(2 subjects)', 'interventionNames': ['Drug: FL058 1000mg（ IV 120min）', 'Drug: FL058 Placebo （ IV 120min）', 'Drug: Meropenem 1000 mg （ IV 120min）', 'Drug: Meropenem Placebo （ IV 120min）', 'Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）', 'Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）']}, {'type': 'EXPERIMENTAL', 'label': 'FL058 1000mg and Meropenem 2000mg (IV 120min)', 'description': 'FL058 1000mg and Meropenem 2000mg (8 subjects);\n\nFL058 Placebo and Meropenem 2000mg(2 subjects)', 'interventionNames': ['Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）', 'Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）']}, {'type': 'EXPERIMENTAL', 'label': 'FL058 1000mg and Meropenem 2000mg (IV 180min)', 'description': 'FL058 1000mg and Meropenem 2000mg (8 subjects);\n\nFL058 Placebo and Meropenem 2000mg(2 subjects)', 'interventionNames': ['Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）', 'Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）']}, {'type': 'EXPERIMENTAL', 'label': 'FL058 2000mg and Meropenem 2000mg', 'description': 'FL058 2000mg and Meropenem 2000mg (8 subjects);\n\nFL058 Placebo and Meropenem 2000mg(2 subjects)', 'interventionNames': ['Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）', 'Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）']}], 'interventions': [{'name': 'FL058 500mg and Meropenem 1000mg（ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 500mg and Meropenem 1000mg']}, {'name': 'FL058 Placebo and Meropenem 1000mg（ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 500mg and Meropenem 1000mg']}, {'name': 'FL058 1000mg（ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'FL058 Placebo （ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'Meropenem 1000 mg （ IV 120min）', 'type': 'DRUG', 'description': 'D4 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'Meropenem Placebo （ IV 120min）', 'type': 'DRUG', 'description': 'D4 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'FL058 1000mg and Meropenem 1000mg （ IV 120min）', 'type': 'DRUG', 'description': 'D7 qd;\n\nD8\\~ D14 q8h;\n\nD15 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'FL058 Placebo and Meropenem 1000mg （ IV 120min）', 'type': 'DRUG', 'description': 'D7 qd;\n\nD8\\~ D14 q8h;\n\nD15 qd;', 'armGroupLabels': ['FL058 1000mg and Meropenem 1000mg']}, {'name': 'FL058 1000mg and Meropenem 2000mg （ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 1000mg and Meropenem 2000mg (IV 120min)']}, {'name': 'FL058 Placebo and Meropenem 2000m（ IV 120min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 1000mg and Meropenem 2000mg (IV 120min)']}, {'name': 'FL058 1000mg and Meropenem 2000mg （ IV 180min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 1000mg and Meropenem 2000mg (IV 180min)']}, {'name': 'FL058 Placebo and Meropenem 2000m（ IV 180min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 1000mg and Meropenem 2000mg (IV 180min)']}, {'name': 'FL058 2000mg and Meropenem 2000mg（ IV 180min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 2000mg and Meropenem 2000mg']}, {'name': 'FL058 Placebo and Meropenem 2000mg（ IV 180min）', 'type': 'DRUG', 'description': 'D1 qd;\n\nD2\\~ D8 q8h;\n\nD9 qd', 'armGroupLabels': ['FL058 2000mg and Meropenem 2000mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}