Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-06 @ 2:59 PM
Study NCT ID:
NCT02106260
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of CLS003', 'timeFrame': '7 days'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '7 days'}, {'measure': 'Peak Plasma Concentration (Cmax) of CLS003', 'timeFrame': '7 days'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'pharmacokinetics (PK)', 'pharmacodynamics (PD)', 'CLS003'], 'conditions': ['Cutaneous Warts']}, 'descriptionModule': {'briefSummary': 'This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.\n* Body mass index (BMI) between 18 and 30kg/m2, inclusive\n* Fitzpatrick skin type I-II-III-IV\n* At least 4 cutaneous warts on the hands, separated by at least 1cm of skin\n\nExclusion Criteria:\n\n* For women, a positive pregnancy test and/or nursing at screening\n* A positive test for drugs of abuse at screening\n* History of alcohol or illicit drug abuse\n* Positive test results for Hepatitis B, Hepatitis C or HIV\n* Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment\n* Have received cryotherapy in the treatment area within 60 days prior to enrollment\n* Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.'}, 'identificationModule': {'nctId': 'NCT02106260', 'briefTitle': 'First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Co., Ltd.'}, 'officialTitle': 'A Phase I/IIa Open-label First-in-Human Study to Assess Safety and Pharmacokinetics and Explore Biomarker Effects of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Subjects With Cutaneous Warts', 'orgStudyIdInfo': {'id': 'CLS003-CO-PR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLS003', 'interventionNames': ['Drug: CLS003']}], 'interventions': [{'name': 'CLS003', 'type': 'DRUG', 'armGroupLabels': ['CLS003']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zernikedreef 8', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research'}], 'overallOfficials': [{'name': 'J. (Koos) Burggraaf, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Human Drug Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}