Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02125435
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626017', 'term': 'ASP2408'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameter of ASP2408:AUClast', 'timeFrame': 'Days 1-8, 15, 22, 29, 43, 60, 90', 'description': 'Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)'}, {'measure': 'Pharmacokinetic parameter of ASP2408: AUCinf', 'timeFrame': 'Days 1 -8, 15, 22, 29, 43, 60, 90', 'description': 'Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)'}, {'measure': 'Pharmacokinetic parameter of ASP2408:Cmax', 'timeFrame': 'Days 1-8, 15, 22, 29, 43, 60, 90', 'description': 'Maximum concentration (Cmax)'}, {'measure': 'Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation', 'timeFrame': 'up to 90 days'}], 'secondaryOutcomes': [{'measure': 'Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot', 'timeFrame': 'Days 1-8, 15, 22, 29, 43, 60, 90', 'description': 'Time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), Terminal phase volume (Vz), Total Body Clearance (CLtot)'}, {'measure': 'Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy', 'timeFrame': 'Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90'}, {'measure': 'Total lymphocyte count', 'timeFrame': 'Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90'}, {'measure': 'Peripheral lymphocyte subset quantification', 'timeFrame': 'Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy subjects', 'ASP2408', 'pharmacokinetics'], 'conditions': ['Healthy Subjects', 'Pharmacokinetics of ASP2408']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.', 'detailedDescription': 'This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.\n* Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator.\n* Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.\n* Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer.\n* Subject is highly likely to comply with the protocol and complete the study.\n\nExclusion Criteria:\n\n* Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer.\n* Subject has a history of severe allergic or anaphylactic reactions.\n* Subject is a female of child-bearing potential.\n* Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).\n* Subject has a positive test for alcohol or drugs of abuse.\n* Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in.\n* Subject has a past history of opportunistic infection.\n* Subject has a supine mean systolic blood pressure \\< 90 or \\> 160 mmHg and a mean diastolic blood pressure \\< 50 or \\> 90 mmHg, or mean pulse rate higher than 100 beats per min (bpm).\n* Subject is known positive for human immunodeficiency virus (HIV) antibody.\n* Subject has a positive TB skin test or Quantiferon Gold test or T-SPOT® test at Screening.\n* Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody.\n* Subject's laboratory test results:\n\n * alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), are greater than 1.5 times the upper limit of normal\n * are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests.\n* Subject received any vaccine within 60 days prior to study drug administration.\n* Subject received any systemic immunosuppressant agent within 2 months prior to study drug administration.\n* Subject has previously received any antibody or therapeutic biologic product prior to study drug administration.\n* Subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration.\n* Subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration.\n* Subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration.\n* Subject is participating in another clinical trial or has participated in another dose group of the current trial.\n* Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.\n* Subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months."}, 'identificationModule': {'nctId': 'NCT02125435', 'briefTitle': 'A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': '2408-CL-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP2408 dose escalation cohort', 'interventionNames': ['Drug: ASP2408']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo dose escalation cohort', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP2408', 'type': 'DRUG', 'description': 'intravenous', 'armGroupLabels': ['ASP2408 dose escalation cohort']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'intravenous', 'armGroupLabels': ['Placebo dose escalation cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'PAREXEL International', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}