Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-21 @ 5:49 AM
Study NCT ID:
NCT02528903
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626824', 'term': 'lesofavumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events, graded by severity', 'timeFrame': 'Until study discontinuation/termination, up to 120 days'}, {'measure': 'Changes in vital signs during and following MHAB5553A administration', 'timeFrame': 'Throughout the study, up to 120 days'}, {'measure': 'Changes in physical examination finding during and following MHAB5553A administration', 'timeFrame': 'Throughout the study, up to 120 days'}, {'measure': 'Changes in clinical laboratory results during and following MHAB5553A administration', 'timeFrame': 'Throughout the study, up to 120 days'}, {'measure': 'Changes in electrocardiogram (ECG) findings during and following MHAB5553A', 'timeFrame': 'Throughout the study, up to 120 days'}, {'measure': 'Incidence of serum anti-MHAB5553A antibodies', 'timeFrame': 'Until study discontinuation/termination, up to 120 days'}], 'secondaryOutcomes': [{'measure': 'Maximum serum concentration (Cmax) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Time to Cmax (tmax) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Clearance (CL) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Volume of distribution at steady-state (Vss) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Terminal elimination half-life (t1/2) of MHAB5553A', 'timeFrame': 'Up to 120 days'}, {'measure': 'Mean Residence Time (MRT) of MHAB5553A', 'timeFrame': 'Up to 120 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '28559255', 'type': 'DERIVED', 'citation': 'Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent form (ICF)\n* Body mass index (BMI) between 18 and 32 kg/m2, inclusive\n* Weight 40-100 kg\n* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs\n* Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening\n* Willing to abstain from using drugs of abuse while enrolled in the study\n* Willing and able to comply with protocol-specified criteria in regard to contraceptive protection\n* Able to comply with the study protocol, in the investigator's judgment\n\nExclusion Criteria:\n\n* History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders\n* History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor\n* History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)\n* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit\n* History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine \\[PCP\\], and crack) within 1 year prior to screening\n* Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in\n* Positive drug screen at screening or at check-in\n* Positive pregnancy test result at screening or Day -1 or breast feeding during the study\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study\n* Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol"}, 'identificationModule': {'nctId': 'NCT02528903', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'GV29827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'interventionNames': ['Drug: MHAB5553A', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B', 'interventionNames': ['Drug: MHAB5553A', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C', 'interventionNames': ['Drug: MHAB5553A', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D', 'interventionNames': ['Drug: MHAB5553A', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort E', 'interventionNames': ['Drug: MHAB5553A', 'Drug: Matching placebo']}], 'interventions': [{'name': 'MHAB5553A', 'type': 'DRUG', 'description': 'Single intravenous administration, at various doses, depending on the cohort', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C', 'Cohort D', 'Cohort E']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Single intravenous dose', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C', 'Cohort D', 'Cohort E']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P 0A2', 'city': 'Québec', 'country': 'Canada', 'facility': 'inVentiv Health Clinique', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}