Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-28 @ 2:48 PM
Study NCT ID:
NCT05851066
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'Lipid profile'}, {'measure': 'Change of total cholesterol (TC) from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'Lipid profile'}, {'measure': 'Change of triglyceride (TG) from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'Lipid profile'}, {'measure': 'Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'Lipid profile'}, {'measure': 'Change of fasting glucose from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'glucose metabolism'}, {'measure': 'Change of HbA1c from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'glucose metabolism'}, {'measure': 'Change of fasting C peptide from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'glucose metabolism'}, {'measure': 'Change of fasting insulin from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'glucose metabolism'}], 'primaryOutcomes': [{'measure': 'Frequency and severity of adverse event (AE) and serious adverse event (SAE)', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'pharmacokinetics (PK)'}, {'measure': 'Time of occurrence of Cmax (tmax) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'PK'}, {'measure': 'Apparent terminal phase half-life (t1/2) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'PK'}, {'measure': 'Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'PK'}, {'measure': 'Apparent clearance (CL/F) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'PK'}, {'measure': 'Apparent terminal phase volume of distribution (Vz/F) of VSA003', 'timeFrame': 'Up to 48 hours post dose', 'description': 'PK'}, {'measure': 'Change of fasting serum ANGPTL3 from pre-dose baseline', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'PD'}, {'measure': 'Anti-drug Antibodies (ADA) to VSA003', 'timeFrame': 'Up to 85±3 days post-dose', 'description': 'immunogenecity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Familial Hypercholesterolemia', 'Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception\n* BMI 18.0\\~28.0 kg/m2\n* Willing to provide written informed consent and to comply with study requirements\n* On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study\n* TG\\> 100 mg/dL\n* LDL-C\\> 70 mg/dL\n\nExclusion Criteria:\n\n* Clinically significant health concerns\n* Regular use of alcohol within one month prior to screening\n* Recent (within 3 months) use of illicit drugs\n* Female with pregnancy or breastfeeding\n* QTcF\\>450 ms in ECG\n* Donation or loss of whole blood more than 400 ml prior to administration of the study treatment\n\nNote: additional inclusion/exclusion criteria may apply, per protocol'}, 'identificationModule': {'nctId': 'NCT05851066', 'briefTitle': 'A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Visirna Therapeutics HK Limited'}, 'officialTitle': 'A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers', 'orgStudyIdInfo': {'id': 'VSA003-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VSA003', 'description': 'single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg', 'interventionNames': ['Drug: VSA003']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'sterile normal saline (0.9% NaCl) calculated volume to match active treatment', 'interventionNames': ['Drug: 0.9% NaCl']}], 'interventions': [{'name': 'VSA003', 'type': 'DRUG', 'description': 'sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg', 'armGroupLabels': ['VSA003']}, {'name': '0.9% NaCl', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visirna Therapeutics HK Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}