Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 9:09 PM
Study NCT ID:
NCT05449535
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'JYB1904/JYB1904 Placebo Arm: double-blind (participant and investigator); Omalizumab Arm: non-blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'Baseline through 168 days post-dose', 'description': 'Incidence and features of AEs assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Serum concentrations of JYB1904 and Omalizumab', 'timeFrame': 'Baseline through 168 days post-dose', 'description': 'Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis'}, {'measure': 'Serum concentrations of total/free IgE', 'timeFrame': 'Baseline through 168 days post-dose', 'description': 'Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis'}, {'measure': 'Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)', 'timeFrame': 'Baseline through 168 days post-dose', 'description': 'Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.', 'detailedDescription': 'This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.\n\nThe sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).\n\nDosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;\n2. Healthy Chinese subjects aged 18-50 years, male or female;\n3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.\n\nExclusion Criteria:\n\n1. Surgery history within 6 months prior to screening or any surgery schedule during the study;\n2. Last visit in previous drug clinical trial within 3 months prior to screening;\n3. Acute diseases occur or receive any medication during the screening period;\n4. Other conditions unsuitable for the study confirmed by the investigator.'}, 'identificationModule': {'nctId': 'NCT05449535', 'briefTitle': 'Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'JY20210115-Ia'}, 'secondaryIdInfos': [{'id': 'CTR20220973', 'type': 'REGISTRY', 'domain': 'National Medical Products Administration of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JYB1904/JYB1904 Placebo', 'description': 'single-dose; subcutaneous injection in the deltoid region of the upper arm.', 'interventionNames': ['Drug: JYB1904', 'Drug: JYB1904 Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab', 'description': 'single-dose; subcutaneous injection in the deltoid region of the upper arm.', 'interventionNames': ['Drug: Omalizumab']}], 'interventions': [{'name': 'JYB1904', 'type': 'DRUG', 'description': 'Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.', 'armGroupLabels': ['JYB1904/JYB1904 Placebo']}, {'name': 'Omalizumab', 'type': 'DRUG', 'otherNames': ['Xolair'], 'description': 'Dosage form: injection, powder, lyophilized, for solution； Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm.', 'armGroupLabels': ['Omalizumab']}, {'name': 'JYB1904 Placebo', 'type': 'DRUG', 'description': 'Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.', 'armGroupLabels': ['JYB1904/JYB1904 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Shulan (Hangzhou) Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Guiling Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shulan (Hangzhou) Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}