Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-28 @ 1:11 AM
Study NCT ID:
NCT06315335
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of TEAEs', 'timeFrame': 'From Baseline Visit up to the End of Study Visit (Week 8)', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharamceutical product administration or an already present event that worsens either in intensity or frequency'}, {'measure': 'Occurrence of treatment-emergent SAEs', 'timeFrame': 'From Baseline up to the End of Study Visit (Week 8)', 'description': 'A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\nResults in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'From Day 1 (predose) up to the End of Study Visit (Week 8)', 'description': 'Cmax: Maximum serum concentration'}, {'measure': 'AUC0-t', 'timeFrame': 'From Day 1 (predose) up to the End of Study Visit (Week 8)', 'description': 'AUC0-t: Area under the curve from 0 to the time of the last quantifiable concentration'}, {'measure': 'AUCinf', 'timeFrame': 'From Day 1 (predose) up to the End of Study Visit (Week 8)', 'description': 'AUCinf: Area under the curve from 0 to infinity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1', 'UCB9741'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\nFor all subjects:\n\n* Male or female between 18 to 55 years old, overtly healthy\n* Female participants must not be pregnant or breastfeeding\n* Female participants must be either of non-childbearing potential or using a highly efficient birth control method\n* Male participants must use acceptable contraception and refrain from sperm donation during the study 90 days\n* Body mass Index within the range 18 to 30 kg/m\\^2 (inclusive)\n\nFor Japanese subjects only:\n\nJapanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents\n\nFor Caucasian subjects only:\n\nCaucasian descent as evidenced in appearance and verbal confirmation of familial heritage and is of Caucasian descent with all 4 grandparents\n\nExclusion criteria:\n\n* Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs or humanized antibodies (mAbs)\n* Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions\n* Participant has abnormal blood pressure (BP) (outside the normal range)\n* Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \\>1.5x upper limit of normal (ULN)\n* Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)\n* Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)\n* Participant has a history of diabetes\n* Study participant has a corrected QT interval (QTc) \\>450msec for male study participants or \\>470msec for female study participants\n* Participant has sensitivity to heparin or heparin-induced thrombocytopenia\n* Participant has a positive test for substance of abuse, or is a regular alcohol consumer defined as an average weekly intake of \\>14 units\n* Participant has received any prescription or nonprescription medicines within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives or occasional use of analgesic\n* Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of investigational medicinal product (IMP)\n* Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit\n* Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP"}, 'identificationModule': {'nctId': 'NCT06315335', 'briefTitle': 'A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A SINGLE CENTER, RANDOMIZED, INVESTIGATOR- AND PARTICIPANT-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, ETHNOBRIDGING PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS AFTER SINGLE-DOSE OF UCB9741 IN HEALTHY CAUCASIAN AND JAPANESE PARTICIPANTS', 'orgStudyIdInfo': {'id': 'UP0118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Caucasian)', 'description': 'Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo', 'interventionNames': ['Drug: UCB9741', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Japanese)', 'description': 'Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo', 'interventionNames': ['Drug: UCB9741', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (Caucasian)', 'description': 'Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo', 'interventionNames': ['Drug: UCB9741', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 (Japanese)', 'description': 'Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo', 'interventionNames': ['Drug: UCB9741', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5 (Caucasian)', 'description': 'Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 (using a different volume per injection than cohort 3) or Placebo', 'interventionNames': ['Drug: UCB9741', 'Drug: Placebo']}], 'interventions': [{'name': 'UCB9741', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.', 'armGroupLabels': ['Cohort 1 (Caucasian)', 'Cohort 2 (Japanese)', 'Cohort 3 (Caucasian)', 'Cohort 4 (Japanese)', 'Cohort 5 (Caucasian)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.', 'armGroupLabels': ['Cohort 1 (Caucasian)', 'Cohort 2 (Japanese)', 'Cohort 3 (Caucasian)', 'Cohort 4 (Japanese)', 'Cohort 5 (Caucasian)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Up0118 10001', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}