Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-24 @ 11:05 PM
Study NCT ID:
NCT01881633
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005776', 'term': 'Gaucher Disease'}], 'ancestors': [{'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'From Screening to Day 5 post-dose', 'description': 'Evaluation for safety data by treatment group/ Confirmative evaluation for serious adverse drug reaction/ Descriptive statistics (arithmetic mean and standard deviation) for quantitative analysis and evaluation of change from baseline/ Frequency counts for qualitative categorization of safety data\n\nParameters:\n\n* Adverse events including subjective/objective symptoms\n* Physical examination\n* 12-lead ECG\n* Vital signs\n* Local tolerability test\n* Clinical laboratory test: Hematology, Coagulation, Blood Chemistry, Urinalysis\n* Immunogenicity'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Day1', 'description': 'Pharmacokinetic Parameter assessment using non-compartmental analysis from the concentration-time data/ Summary of Pharmacokinetic parameters by treatment group using descriptive statistics/ Dose proportionality\n\nParameters: Cmax, AUCt, AUCinf, Tmax, t1/2, Clearance, Vd, MRTr'}]}, 'conditionsModule': {'keywords': ['gaucher disease, imiglucerase, ISU302'], 'conditions': ['Gaucher Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers, aged between ≥ 20 and ≤ 45 years old\n* Weight ≥ 50, with calculated body mass index of 17 and 25 kg/m2\n\n * BMI = (Weight \\[kg\\])/(height \\[m\\])2\n* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written\n* Considered ineligible through screening test (such as medical history, physical examination, ECG, safety laboratory test) performed within 35 days prior to study start (dosing of investigational products)\n\nExclusion Criteria:\n\n* With symptoms indicating acute diseases within 28 days prior to start of study (dosing of investigational product)\n* History or presence of clinically significant and active cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor\n* Any medical history that may affect drug absorption, distribution, metabolism and excretion(e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic or renal disease)\n* With presence of clinically significant allergic disease (including mild allergic rhinitis or allergic dermatitis which does not need medication)\n* With presence of clinically significant hypersensitivity to any drugs\n* With hemolytic anemia, anemia due to blood loss (Hb \\< 14g/dL and Hct \\<42%)\n* With the results of safety laboratory test\n\n 1. AST (Aspartate Transaminase) or ALT (Alanine Transaminase) \\> 1.5 times of upper normal limit\n 2. Total bilirubin \\> 1.5 times of upper normal limit\n* Subject who has immune deficiency or medication with immune suppressants\n* Participation in other clinical study within 60 days prior to start of study (dosing of investigational products)\n* Use of any drugs, possibly affecting drug metabolizing enzymes, within 1 month prior dosing, or any drugs, possibly affecting the results of clinical trial within 10 days or use of drug was not passes 5 x half-life of drug\n* Donated whole blood within 60 days, or transfused within 20 days before the study\n* History of alcohol abuse (\\> 14 units/week) and the subject could not stop drinking alcohol beverage during study period\n* Heavy smoker (\\>10 cigarettes/day) or the subject could not stop smoking during study period\n* Unwillingness or inability to follow the procedures outlined in the protocol\n* Positive in pregnancy test in urine and unwilling to follow contraception during study period and following 3 months (for female subjects).'}, 'identificationModule': {'nctId': 'NCT01881633', 'briefTitle': 'A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ISU Abxis Co., Ltd.'}, 'officialTitle': 'A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ISU-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISU302', 'description': '15 U/kg I.V. injection', 'interventionNames': ['Drug: ISU302']}, {'type': 'EXPERIMENTAL', 'label': 'ISU302 30 U/kg', 'description': 'Drug ISU302 I.V. injection', 'interventionNames': ['Drug: ISU302']}, {'type': 'EXPERIMENTAL', 'label': 'ISU302 60 U/kg', 'description': 'Drug ISU302 I.V. injection', 'interventionNames': ['Drug: ISU302']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'ISU302 Placebo I.V. injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ISU302', 'type': 'DRUG', 'armGroupLabels': ['ISU302', 'ISU302 30 U/kg', 'ISU302 60 U/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ISU Abxis Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}