Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT06716151
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with drug related adverse events (AEs)', 'timeFrame': 'up to 113 days', 'description': 'An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 113 days', 'description': 'The maximum measured concentration of the analysis in plasma'}, {'measure': 'AUC0-infinity', 'timeFrame': 'up to 113 days', 'description': 'The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.', 'detailedDescription': 'This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects age ≥ 18 and ≤ 55 years.\n* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².\n* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.\n\nSigned and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n\nExclusion Criteria:\n\n\\- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.\n\nCurrent or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)\n\n* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).\n* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.\n* Further exclusion criterias apply.'}, 'identificationModule': {'nctId': 'NCT06716151', 'briefTitle': 'A Study to Evaluate HB0034 in Healthy Chinese Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Huaota Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects', 'orgStudyIdInfo': {'id': 'HB0034-HV-01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 1', 'description': '6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 2', 'description': '6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 3', 'description': '6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 4', 'description': '6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 5', 'description': '6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 6', 'description': '8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator: HB0034 dose group 7', 'description': '8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody', 'interventionNames': ['Drug: HB0034']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '17 subjects receive placebo', 'interventionNames': ['Drug: HB0034 matching placebo']}], 'interventions': [{'name': 'HB0034', 'type': 'DRUG', 'description': 'Recombinant Humanized Anti-IL-36R Monoclonal antibody', 'armGroupLabels': ['Active Comparator: HB0034 dose group 1', 'Active Comparator: HB0034 dose group 2', 'Active Comparator: HB0034 dose group 3', 'Active Comparator: HB0034 dose group 4', 'Active Comparator: HB0034 dose group 5', 'Active Comparator: HB0034 dose group 6', 'Active Comparator: HB0034 dose group 7']}, {'name': 'HB0034 matching placebo', 'type': 'DRUG', 'description': 'HB0034 matching Palcebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Cuigang', 'role': 'CONTACT', 'email': 'zxyyywsy@163.com', 'phone': '+860531-55566416'}, {'name': 'Qing Wen', 'role': 'CONTACT'}], 'facility': 'Central Hospital affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuan Tang', 'role': 'CONTACT', 'email': 'yuan.tang@huaota.com', 'phone': '+86 15821321563'}, {'name': 'Qiaoxia Qian', 'role': 'CONTACT', 'email': 'qiaoxia.qian@huaota.com', 'phone': '+86 18555690860'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Huaota Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}