Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT07124468
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPlasma、CELF、CAM', 'timeFrame': '5 days', 'description': 'Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. The main question it aims to answer is:\n\n• \\[question 1\\] : What are the concentrations of meropenem and Pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at each time point'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 18-45 years\n* Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.\n* Pulmonary function at screening:\n\n 1. Forced expiratory volume in 1 second (FEV₁) measured/predicted \\>80%\n 2. Forced vital capacity (FVC) measured/predicted \\>80%\n 3. All other ventilation and diffusion parameters normal or with no clinical significance.\n* Participant capability:\n\n 1. Ability to communicate effectively with investigators\n 2. Willingness to comply with study procedures\n 3. Voluntary participation with acceptance of bronchoalveolar lavage (BAL)\n 4. Provision of written informed consent.\n* Reproductive planning:\n\n 1. No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose\n 2. Participant and partner must use protocol-approved contraception.\n\nExclusion Criteria:\n\n* Hypersensitivity to cephalosporins or carbapenem antibiotics.\n* History or current diagnosis of respiratory system diseases.\n* History or current diagnosis of coagulation disorders.\n* Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems judged by the investigator to interfere with study outcomes.\n* History of smoking or positive nicotine test during screening.\n* Prior surgery involving pharynx, trachea/bronchi, or lungs.\n* Drug abuse history within 1 year prior to screening or positive urine drug screen at screening.\n* Alcohol intake \\>14 units/week on average within 6 months prior to screening.\n* Participation in other clinical trials with investigational drugs/devices within 3 months prior to screening.\n* Blood donation/loss ≥400 mL or blood product transfusion within 3 months prior to screening.\n* Respiratory infections (bacterial/fungal/viral) within 2 weeks prior to screening (e.g., upper/lower respiratory tract infections).\n* Use of any medication/vaccination within 14 days prior to screening or planned vaccination during the study.\n* Clinically significant abnormalities in physical examination, 12-lead ECG, or imaging at screening per investigator's judgment.\n* Pregnancy, lactation, or positive serum pregnancy test at screening."}, 'identificationModule': {'nctId': 'NCT07124468', 'briefTitle': 'Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label, Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'FL058-Ⅰ-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Meropenem-Pralubactam', 'interventionNames': ['Drug: Meropenem-Pralubactam']}], 'interventions': [{'name': 'Meropenem-Pralubactam', 'type': 'DRUG', 'description': 'The study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam', 'armGroupLabels': ['Intravenous Meropenem-Pralubactam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pinfang Huang, bachelor', 'role': 'CONTACT', 'email': '2363869908@qq.com', 'phone': '0591- 87981331'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Pinfang Huang, bachelor', 'role': 'CONTACT', 'email': '2363869908@qq.com', 'phone': '0591- 87981331'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}