Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-31 @ 6:37 AM
Study NCT ID:
NCT07148557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Single Dose of LP-003 in Adolescent Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012847', 'term': 'Single Person'}], 'ancestors': [{'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AE)', 'timeFrame': 'Observation for 196 days after administration', 'description': 'Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).'}], 'secondaryOutcomes': [{'measure': 'Time to peak concentration (Tmax) of LP-003', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The time when the blood drug concentration reaches its peak after a single dose of medication.'}, {'measure': 'Maximum concentration (Cmax) of LP-003', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The maximum concentration of LP-003 in the bloodstream after administration.'}, {'measure': 'Elimination half-life (t1/2) of LP-003', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The time required for the concentration of LP-003 in the bloodstream to decrease by half.'}, {'measure': 'Area under the concentration-time curve (AUC0-t) of LP-003', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration.'}, {'measure': 'Apparent clearance rate (CL/F) of LP-003', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.'}, {'measure': 'Assessment of total immunoglobulin E (IgE)', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The changes in serum total IgE levels compared to baseline at different assessment time points.'}, {'measure': 'Assessment of free immunoglobulin E (IgE)', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The changes in serum free IgE levels compared to baseline at different assessment time points.'}, {'measure': 'Assessment of immunogenicity', 'timeFrame': 'Observation for 196 days after administration', 'description': 'The proportion of anti drug antibody (ADA) positive subjects at different detection time points.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Spontaneous Urticaria (CSU)', 'Seasonal Allergic Rhinitis (SAR)']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescent subjects aged ≥12 years and \\<18 years, male or female.\n* History of allergic diseases (self-reported is acceptable), including, but not limited to, food allergies, allergic rhinitis, allergic asthma, urticaria, and atopic dermatitis.\n* Agreement to use effective contraception during the study and for 6 months after the end of the study.\n* Subject and parent or legal guardian able to understand and voluntarily sign the informed consent form, and comply with study visits and related procedures.\n\nExclusion Criteria:\n\n* Allergic to LP-003 or its excipients.\n* Any serious or uncontrolled chronic disease (e.g., severe arrhythmia, ischemic heart disease, NYHA Class III/IV heart failure, severe pulmonary disease, inadequately controlled asthma, hypertension, diabetes, hypo- or hyperthyroidism) that may affect subject safety as determined by the Investigator.\n* History of severe allergic reactions.\n* Abnormal venous access, venipuncture or subcutaneous injection intolerance, history of needle or blood phobia.\n* Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m² at screening.\n* ALT or AST \\> ULN and considered clinically significant by the Investigator.\n* Any other abnormal screening test result that, in the Investigator's opinion, could affect subject safety or study assessments.\n* Systemic corticosteroid therapy (intravenous, intramuscular, or oral) within 4 weeks prior to study drug administration.\n* Use of medications known to interact with epinephrine (e.g., β-blockers, ACE inhibitors, tricyclic antidepressants) within 4 weeks prior to administration.\n* Use of biologic products (e.g., omalizumab) within 6 months prior to administration.\n* Receipt vaccines within 14 days before administration or planning vaccination during the study.\n* Participation in other clinical trials within 3 months prior to screening or within 5 half-lives of investigational product discontinuation (whichever is longer).\n* Any other conditions that the Investigator considers subjects unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT07148557', 'briefTitle': 'A Study of Single Dose of LP-003 in Adolescent Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Longbio Pharma'}, 'officialTitle': 'A Single-center, Open-label, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of LP-003 Injection in Adolescent Subjects Aged 12-18 Years', 'orgStudyIdInfo': {'id': 'P10-LP003-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: LP-003 Dose 1 (Single)', 'interventionNames': ['Biological: LP-003 Dose 1 (Single)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 : LP-003 Dose 2 (Single)', 'interventionNames': ['Biological: LP-003 Dose 2 (Single)']}], 'interventions': [{'name': 'LP-003 Dose 1 (Single)', 'type': 'BIOLOGICAL', 'description': 'A single dose of LP-003 (400 mg/dose) was SC', 'armGroupLabels': ['Cohort 1: LP-003 Dose 1 (Single)']}, {'name': 'LP-003 Dose 2 (Single)', 'type': 'BIOLOGICAL', 'description': 'A single dose of LP-003 (600 mg/dose) was SC', 'armGroupLabels': ['Cohort 2 : LP-003 Dose 2 (Single)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Longbio Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}