Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-28 @ 3:25 AM
Study NCT ID:
NCT01093859
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Phase 1 Microdose Study of PRX-105
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000602637', 'term': 'PRX-105'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2010-03-24', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRX-105 plasma concentration', 'timeFrame': '0 to 48 hours after injection', 'description': 'Assessment of pharmacokinetics'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular monitoring', 'timeFrame': '0 to 48 hours after injection', 'description': 'Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation.'}, {'measure': 'Neurological examination', 'timeFrame': '0 to 48 hours', 'description': 'Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking'}, {'measure': 'Ophthalmic evaluation', 'timeFrame': '0 to 8 hours', 'description': 'pupillar light reaction, accommodation, visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acetylcholinesterase'], 'conditions': ['Organophosphate Exposure']}, 'descriptionModule': {'briefSummary': 'Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male volunteers aged 18-45 (inclusive) years.\n* Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.\n* Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.\n* Blood pressure and heart rate within normal limits.\n* Electrocardiogram (ECG) with no clinically significant abnormalities.\n\nExclusion Criteria:\n\n* History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.\n* Current / previous occupational exposure to organophosphates or pesticides.\n* Previous receipt of any investigational butyrylcholinesterase product."}, 'identificationModule': {'nctId': 'NCT01093859', 'briefTitle': 'An Exploratory Phase 1 Microdose Study of PRX-105', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protalix'}, 'officialTitle': 'An Exploratory Phase 1 Study to Assess the Safety and Pharmacokinetics of PRX-105, Administered as a Single, Microdose, Intravenous Slow Bolus Injection to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PB-09-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRX-105 Infusion', 'interventionNames': ['Drug: PRX-105']}], 'interventions': [{'name': 'PRX-105', 'type': 'DRUG', 'description': 'Sterile solution for intravenous injection', 'armGroupLabels': ['PRX-105 Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Einat Almon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Protalix Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protalix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}