Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02346760
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 70 or 112 days'}], 'secondaryOutcomes': [{'measure': 'Peak concentration of UB-621', 'timeFrame': 'Up to 70 or 112 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Herpes Simplex Virus Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.', 'detailedDescription': 'This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With age between 20 and 55 years.\n* With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.\n* Body weight: \\<85 kg.\n* Subject has signed the written informed consent form.\n\nExclusion Criteria:\n\n* With significant active infection (acute or chronic) within 28 days prior to the screening visit.\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.\n* Positive serology for HIV antibody, HCV antibody or HBV surface antigen.\n* Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.\n* The clinical investigator considers that the subject is not in the condition to participate in this study.'}, 'identificationModule': {'nctId': 'NCT02346760', 'briefTitle': 'Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'United BioPharma'}, 'officialTitle': 'A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A101-HSV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UB-621', 'description': 'Intervention drug: UB-621', 'interventionNames': ['Drug: UB-621']}], 'interventions': [{'name': 'UB-621', 'type': 'DRUG', 'description': '100 mg/ml, subcutaneous injection', 'armGroupLabels': ['UB-621']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wing Wai Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hoapital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United BioPharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}