Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 10:13 AM
Study NCT ID:
NCT05542303
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0', 'timeFrame': 'during the study, up to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'ZB001 concentrations in the blood over time', 'timeFrame': 'Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks', 'description': 'PK parameters in the blood over time.'}, {'measure': 'Serum ZB001 antidrug antibody (ADA) titers', 'timeFrame': 'Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks', 'description': 'antidrug antibody (ADA) titers of ZB001'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening\n2. Free of any clinically significant disease or medical condition at screening as determinedby the Investigator\n3. Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2\n4. Women must be of non-childbearing potential:Surgically sterile; no menses for ≥ 12 months AND a follicle-stimulating hormone level\\>40 IU/L at screening; or meeting the definition of "postmenopausal range" based onscreening laboratory results\n5. Willing and able to comply with all the study requirements and provide written informedconsent for the study\n\nExclusion Criteria:\n\n1. Donated blood or experienced significant blood loss\n2. Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug\n3. History of or have any evidence of diabetes mellitus\n4. History of renal impairment or inflammatory bowel disease\n5. History of clinically significant ear pathology, ear surgery, or hearing impairment\n6. Active infection\n7. History of malignancy\n8. Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.\n9. Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study\n10. Received the last dose of an investigational drug or treatment with a medical devicewithin 30 days or 5 half-lives prior to screening or currentlyparticipating in another study of an investigational drug or medical device\n11. Previously participated in a study of IGF-1 or IGF-1R-related products\n12. Any medical condition or laboratory abnormality, that in the opinion of the Investigator, would prevent the subject from completing the study, pose a risk to the subject, or confound the ability to interpret study results'}, 'identificationModule': {'nctId': 'NCT05542303', 'briefTitle': 'A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zenas BioPharma (USA), LLC'}, 'officialTitle': 'A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'ZB001-01-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZB001 for injection', 'description': 'Treated different dose cohorts with single intravenous injection of ZB001', 'interventionNames': ['Drug: ZB001 for injection']}], 'interventions': [{'name': 'ZB001 for injection', 'type': 'DRUG', 'description': 'Dose Cohort1 (3mg/kg) ZB001 of single IV injection', 'armGroupLabels': ['ZB001 for injection']}, {'name': 'ZB001 for injection', 'type': 'DRUG', 'description': 'Dose Cohort2 (10mg/kg) ZB001 of single IV injection', 'armGroupLabels': ['ZB001 for injection']}, {'name': 'ZB001 for injection', 'type': 'DRUG', 'description': 'Dose Cohort3 (20mg/kg) ZB001 of single IV injection', 'armGroupLabels': ['ZB001 for injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zenas BioPharma (USA), LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}