Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05058118
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-03', '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': '2020-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events [Safety and Tolerability]', 'timeFrame': 'Day 1 to Day 7'}], 'secondaryOutcomes': [{'measure': 'FL058 -Cmax', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.'}, {'measure': 'FL058 -AUC', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.'}, {'measure': 'FL058 -t1/2', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.'}]}, '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': 'To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese 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': 'NCT05058118', 'briefTitle': 'Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Single-Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.', 'orgStudyIdInfo': {'id': 'FL058-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FL058', 'description': 'a single ascending dose (SAD) of intravenous (IV) FL058(50mg\\~2000mg)', 'interventionNames': ['Drug: FL058']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'FL058 Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'FL058', 'type': 'DRUG', 'description': '50mg、250mg、500mg、1000mg、1500mg、2000mg', 'armGroupLabels': ['FL058']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'empty bottle', 'armGroupLabels': ['Placebo']}]}, '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'}}}}