Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:23 AM
Study NCT ID:
NCT01262794
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2010-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592400', 'term': 'olokizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-26', 'studyFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2010-12-16', 'lastUpdatePostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum drug concentration (Cmax)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}, {'measure': 'Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}, {'measure': 'Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}, {'measure': 'Terminal elimination half-life (T½)', 'timeFrame': 'Multiple sampling from 0 to 113 days following single dose'}], 'secondaryOutcomes': [{'measure': 'PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects', 'timeFrame': 'Multiple sampling from 0 to 15 weeks following single dose'}, {'measure': 'Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects', 'timeFrame': 'Multiple sampling from 0 to 15 weeks following single dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers', 'Japanese'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.\n\nTo evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese volunteers\n\nExclusion Criteria:\n\n* Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.\n* Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)'}, 'identificationModule': {'nctId': 'NCT01262794', 'briefTitle': 'Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males', 'orgStudyIdInfo': {'id': 'RA0074'}, 'secondaryIdInfos': [{'id': '2010-022543-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDP6038 0.3 mg/kg', 'interventionNames': ['Biological: CDP6038']}, {'type': 'EXPERIMENTAL', 'label': 'CDP6038 1 mg/kg', 'interventionNames': ['Biological: CDP6038']}, {'type': 'EXPERIMENTAL', 'label': 'CDP6038 3 mg/kg', 'interventionNames': ['Biological: CDP6038']}, {'type': 'EXPERIMENTAL', 'label': 'CDP6038 6 mg/kg', 'interventionNames': ['Biological: CDP6038']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'CDP6038', 'type': 'BIOLOGICAL', 'description': '100 mg/mL solution for injection, single dose', 'armGroupLabels': ['CDP6038 0.3 mg/kg', 'CDP6038 1 mg/kg', 'CDP6038 3 mg/kg', 'CDP6038 6 mg/kg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride for injection Single-dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}