Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT05053334
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2021-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'AUC0-inf will be evaluated'}, {'measure': 'To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Cmax will be evaluated'}], 'secondaryOutcomes': [{'measure': 'To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'AUC0-t'}, {'measure': 'To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Vd'}, {'measure': 'To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Tmax, T½'}, {'measure': 'To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Free IgE levels will be assessed'}, {'measure': 'To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Total IgE levels will be assessed'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Assessment of Vital signs-Blood pressure'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Assessment of Vital signs-Pulse rate'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Assessment of Vital signs-Body temperature'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Upto 127 Days', 'description': 'Assessment of Vital signs-Respiratory rate'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)', 'description': 'Normal 12 Lead ECG (Ventricular rate)'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)', 'description': 'Normal 12 Lead ECG (PR interval)'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)', 'description': 'Normal 12 Lead ECG (QRS complex)'}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)', 'description': "Normal 12 Lead ECG (QT interval and QT interval corrected for heart rate using Bazett's formula)"}, {'measure': 'Safety & tolerability of BP11 with US-Xolair and EU-Xolair', 'timeFrame': 'Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.', 'description': 'Assessment of injection site reaction'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.', 'detailedDescription': 'The study will be conducted at 2 sites in New Zealand and 1 site in Australia.\n\nA total of 165 healthy male subjects (55 subjects per arm) who meet the required entry criteria will be randomly assigned to one of 3 treatment groups in a 1:1:1 ratio to receive a single SC injection of either BP11, EU-Xolair, or US-Xolair.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator.\n2. Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.\n3. Subjects who are considered healthy as determined by clinically acceptable findings of hematology, clinical chemistry, coagulation profile, urinalysis, and 12-lead ECG as per investigator's discretion.\n4. Subject must agree to use a highly effective contraception as detailed in Appendix 1(Section 13.1) during the study period (starting from screening visit) and until 9 months after administration of BP11, Xolair® -EU or Xolair® -US by agreeing to use (with their female partner if she is of childbearing potential) 2 acceptable forms of contraception.\n5. Subjects must refrain from donating sperm or fathering a child during the study period (starting from screening visit) and until 9 months after administration of BP11, Xolair®-EU or Xolair®-US administration by agreeing to use (with their female partner if she is of childbearing potential) 2 acceptable forms of contraception.\n\nExclusion Criteria:\n\n1. Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.\n2. History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.\n3. Abnormal and clinically relevant (in the opinion of the Investigator) vital signs, ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.\n4. Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.\n5. Difficulty in blood sampling or difficulty in accessibility of veins.\n6. History of significant alcohol abuse within 1 years prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week \\[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\\]).\n7. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n8. Subjects with positive drug test at screening or admission."}, 'identificationModule': {'nctId': 'NCT05053334', 'briefTitle': 'Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair', 'organization': {'class': 'OTHER', 'fullName': 'Syneos Health'}, 'officialTitle': 'A Randomized Phase I, Double-Blinded, Parallel Comparative Assessment of PK, PD, Safety, and Immunogenicity of BP11 Versus US-Licensed Xolair® and EU Approved-Xolair® Following a Single 150 mg Dose SC Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'BP11-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BP11 (Proposed biosimilar)', 'description': 'Subcutaneous injection of Omalizumab developed by CuraTeQ.', 'interventionNames': ['Drug: Omalizumab Prefilled Syringe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US-Xolair', 'description': 'Subcutaneous injection of Omalizumab licensed for use in USA', 'interventionNames': ['Drug: Omalizumab Prefilled Syringe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-Xolair', 'description': 'Subcutaneous injection of Omalizumab approved for use in Europe.', 'interventionNames': ['Drug: Omalizumab Prefilled Syringe']}], 'interventions': [{'name': 'Omalizumab Prefilled Syringe', 'type': 'DRUG', 'description': '150mg/ml of Omalizumab prefilled syringe', 'armGroupLabels': ['BP11 (Proposed biosimilar)', 'EU-Xolair', 'US-Xolair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Herston', 'state': 'Queens Land', 'country': 'Australia', 'facility': 'Q-Pharm Pty Ltd', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '1010', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Clinical Studies Ltd (NZCR OpCo Limited)', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syneos Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'CuraTeQ Biologics Private Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}