Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT01540760
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MCAF5352A in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 5 months'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Area under the concentration-time curve', 'timeFrame': 'Pre-dose and 5 time points up to 14 days post-dose'}, {'measure': 'Immunogenicity: Serum MCAF5252A antibodies', 'timeFrame': 'Days 1, 29, 50, 78, 106 and 134'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females, 18 - 55 years of age\n* Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests\n* Body weight between 45 kg and 110 kg\n* Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Positive for hepatitis B, hepatitis C or HIV infection\n* History of significant chronic or recurrent infections\n* History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug\n* History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse\n* Subjects who have previously received the study drug\n* Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater'}, 'identificationModule': {'nctId': 'NCT01540760', 'briefTitle': 'A Study of MCAF5352A in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'GA28006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCAF5352A', 'interventionNames': ['Drug: MCAF5352A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MCAF5352A', 'type': 'DRUG', 'description': 'Multiple ascending doses', 'armGroupLabels': ['MCAF5352A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching MCAF5352A, multiple doses', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P 0A2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}