Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT02873767
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events during the study', 'timeFrame': 'Day 1 up to Day 57', 'description': 'An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19'}, {'measure': 'Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]', 'timeFrame': 'Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': 'Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19'}, {'measure': 'Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7', 'timeFrame': 'Predose (Day 1), Day 7'}, {'measure': 'Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10', 'timeFrame': 'Predose (Day 1), Day 10'}, {'measure': 'Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13', 'timeFrame': 'Predose (Day 1), Day 13'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['First in human', 'Healthy volunteers'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good physical and mental health\n* At least 18 and less than 65 years of age\n* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug\n\nExclusion Criteria:\n\n* Total Immunoglobulin G \\<7 g/L or \\>16 g/L at the Screening Visit\n* Absolute neutrophil count \\<1.5x10\\^9/L and/or lymphocyte count \\<1.0x10\\^9/L\n* Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive\n* Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies\n* Past medical history or family history of primary immunodeficiency\n* Evidence of latent/active Tuberculosis (TB)\n* Active infection or a serious infection within 6 weeks before the first dose of IMP\n* Renal impairment\n* Hepatic impairment\n* Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period\n* Subject is splenectomized\n* received any IMP or experimental procedure within 90 days before the first dose of IMP\n* received UCB7665 in a clinical study'}, 'identificationModule': {'nctId': 'NCT02873767', 'briefTitle': 'A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'UP0028'}, 'secondaryIdInfos': [{'id': '2016-000772-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single dose placebo comparator for each active arm', 'interventionNames': ['Other: PL1']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4019 Dose 1', 'description': 'Dose 1 calculated based on body weight', 'interventionNames': ['Drug: PR1']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4019 Dose 2', 'description': 'Dose 2 calculated based on body weight', 'interventionNames': ['Drug: PR1']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4019 Dose 3', 'description': 'Dose 3 calculated based on body weight', 'interventionNames': ['Drug: PR1']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4019 Dose 4', 'description': 'Dose 4 calculated based on body weight', 'interventionNames': ['Drug: PR1']}], 'interventions': [{'name': 'PR1', 'type': 'DRUG', 'description': '* Active substance: UCB4019\n* Route of Administration: subcutaneously', 'armGroupLabels': ['UCB4019 Dose 1', 'UCB4019 Dose 2', 'UCB4019 Dose 3', 'UCB4019 Dose 4']}, {'name': 'PL1', 'type': 'OTHER', 'description': '* Active substance: Placebo\n* Concentration: 0.9 % saline\n* Route of Administration: subcutaneously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Up0028 001', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB (+1 887 822 9493)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma S.P.R.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}