Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 4:27 AM
Study NCT ID:
NCT06279533
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2024-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules
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': 'PK characteristics of multiple ascending doses study is double-blinded, placebo-controlled design, and FE study is open-label design'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PK characteristics of multiple ascending doses study is parallel design, and FE study is crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-25', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'Calculated using concentration data collected from predose to 72 hours postdose', 'description': 'Maximum observed plasma concentration'}, {'measure': 'Cmax', 'timeFrame': 'Calculated using concentration data collected from predose to 72 hours postdose', 'description': 'Maximum observed plasma concentration'}, {'measure': 'T1/2', 'timeFrame': 'Calculated using concentration data collected from predose to 72 hours postdose', 'description': 'Terminal half life'}, {'measure': 'AUC0-t', 'timeFrame': 'Calculated using concentration data collected from predose to 72 hours postdose', 'description': 'Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration'}, {'measure': 'AUC0-24h', 'timeFrame': 'Calculated using concentration data collected from predose to 24 hours postdose', 'description': 'Area under the serum concentration time profile from time zero to the time of 24h'}, {'measure': 'AUC0-â', 'timeFrame': 'Calculated using concentration data collected from predose to 72 hours postdose', 'description': 'Area under the plasma concentration-time curve from time 0 extrapolated to infinity'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment emergent treatment-related adverse event(s)', 'timeFrame': 'Dosing through follow-up call (7 days after last dose of investigational product)', 'description': 'Frequency, severity and causal relationship of treatment emergent adverse events'}, {'measure': 'Laboratory test', 'timeFrame': 'Dosing through follow-up call (7 days after last dose of investigational product)', 'description': 'Number of participants with laboratory test findings of potential clinical importance'}, {'measure': 'Vital signs', 'timeFrame': 'Dosing through follow-up call (7 days after last dose of investigational product)', 'description': 'Number of participants with vital signs findings of potential clinical importance'}, {'measure': 'Number of participants with ECG findings of potential clinical importance', 'timeFrame': 'Dosing through follow-up call (7 days after last dose of investigational product)', 'description': 'Number of subjects with change from baseline in electrocardiogram (ECG) parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LV232', 'Phase I', 'dose-escalation', 'Tolerability', 'Pharmacokinetic', 'food effect'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement.', 'detailedDescription': 'PK characteristics of multiple ascending doses study is used randomized, double-blinded, placebo-controlled, single-center design. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (15mg, 40mg and 60mg), 8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. Investigational product is orally administrated QD for day1, day3\\~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted.\n\nFE study is a single-center, randomized, open-label, three-period crossover design. 24 healthy subjects divided into 2 groups (20mgã60mg) will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. The wash-out period is 5 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 18 to 45 years old, males or females;\n2. Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;\n3. Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;\n4. Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;\n5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with hypersensitivity to LV232 or any of the excipients;\n2. Subjects with allergic diseases or allergic constitution;\n3. Subjects with skin diseases or a history of skin allergies;\n4. Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;\n5. Blood donation or blood loss ⥠400 mL within 3 months , or have a history of blood product use history\n6. Subjects who have participated in clinical trials of other drugs within 3 months before screening;\n7. Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;\n8. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit â200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content);\n9. Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;\n10. Subjects who can't quit smoking and drinking during the experiment;\n11. Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);\n12. Abnormal and clinically significant chest radiographs (anteroposterior);\n13. B ultrasound examination showed moderate to severe fatty liver;\n14. Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;\n15. The investigator believes that there are other factors that are not suitable for participating in this trial."}, 'identificationModule': {'nctId': 'NCT06279533', 'briefTitle': 'Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vigonvita Life Sciences'}, 'officialTitle': 'Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules in Chinese Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LV232-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PK characteristics of multiple ascending doses study', 'description': 'There are 24 subjects devided into 3 dose groups (15mg, 40mg and 60mg).8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. Investigational product is orally administrated QD for day1, day3\\~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted.', 'interventionNames': ['Drug: LV232/Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'FE study', 'description': '24 healthy subjects divided into 2 group (20mg and 60mg) will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. Wash-out period is 5 days.', 'interventionNames': ['Drug: LV232']}], 'interventions': [{'name': 'LV232/Placebo', 'type': 'DRUG', 'otherNames': ['LV232 15mg', 'LV232 40mg', 'LV232 60mg'], 'description': 'Drug: LV232 15mg Group:\n\n6 subjects will receive LV232 15mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.\n\nDrug: LV232 40mg Group:\n\n6 subjects will receive LV232 40mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.\n\nDrug: LV232 60mg Group:\n\n6 subjects will receive LV232 60mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.', 'armGroupLabels': ['PK characteristics of multiple ascending doses study']}, {'name': 'LV232', 'type': 'DRUG', 'otherNames': ['LV232 20mg', 'LV232 60mg'], 'description': 'Drug: LV232 20mg Group:\n\n12 subjects will receive LV232 20mg, orally\n\nDrug: LV232 60mg Group:\n\n12 subjects will receive LV232 60mg, orally', 'armGroupLabels': ['FE study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Xuhui Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chen Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Xuhui Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vigonvita Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}