Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01423318
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C561806', 'term': 'lebrikizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-23', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events in healthy Japanese subjects', 'timeFrame': '120 days'}, {'measure': 'Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)', 'timeFrame': '120 days'}], 'secondaryOutcomes': [{'measure': 'Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects', 'timeFrame': 'approximately 5 months'}, {'measure': 'Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects', 'timeFrame': 'approximately 5 months'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy males and females, 18 to 55 years of age inclusive\n* Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation\n* Body weight between 45 and 105 kg, inclusive\n* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations\n* Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion\n* Negative for hepatitis B, hepatitis C, and HIV infection\n* Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol)\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components\n* History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure\n* Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study\n* Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine \\>500 ng/mL. Minimal/intermittent smoking will be permitted during the study\n* Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1)\n* History of significant, chronic, or recurrent infections requiring treatment'}, 'identificationModule': {'nctId': 'NCT01423318', 'briefTitle': 'A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of Lebrikizumab in Healthy Japanese and Caucasian Volunteers', 'orgStudyIdInfo': {'id': 'GB25741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: lebrikizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'lebrikizumab', 'type': 'DRUG', 'description': 'Dose-level cohorts receiving single subcutaneous dose', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'single dose subcutaneously', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}