Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-26 @ 8:57 AM
Study NCT ID:
NCT05370950
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2022-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, random, parallel, open-label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-05-07', 'studyFirstSubmitQcDate': '2022-05-07', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)', 'timeFrame': 'Days 1-113'}, {'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)', 'timeFrame': 'Days 1-113'}, {'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)', 'timeFrame': 'Days 1-113'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)', 'timeFrame': 'Days 1-113'}, {'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)', 'timeFrame': 'Days 1-113'}, {'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)', 'timeFrame': 'Days 1-113'}, {'measure': 'Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)', 'timeFrame': 'Days 1-113'}, {'measure': 'Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.', 'timeFrame': 'Days 1-113'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia and Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '40587053', 'type': 'DERIVED', 'citation': 'Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.'}, {'pmid': '40252193', 'type': 'DERIVED', 'citation': 'Wang Y, Cheng Y, Guo Y, Fan Y, Zhou R, Zhang Q, Xu Y, Feng S, Shen K, Hu W. A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. Eur J Drug Metab Pharmacokinet. 2025 May;50(3):265-272. doi: 10.1007/s13318-025-00944-5. Epub 2025 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;\n2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;\n3. Body mass index (BMI) at screening period must be ≥18.5 kg/m2 and \\<30.0 kg/m2, weight of male must≥ 50.0 kg and \\<90.0 kg, and female≥ 45.0 kg and \\<90.0 kg;\n4. The subjects and their female partners are willing to have no reproductive plan from 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.\n\nExclusion Criteria:\n\n1. History of the following diseases or treatments:\n\n Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).\n2. Any one of the following tests at Screening period or Baseline period:\n\n Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.\n3. General situation:\n\n Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.\n4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.'}, 'identificationModule': {'nctId': 'NCT05370950', 'briefTitle': 'Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SHR-1209-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'interventionNames': ['Drug: SHR-1209']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'interventionNames': ['Drug: SHR-1209']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group C', 'interventionNames': ['Drug: SHR-1209']}], 'interventions': [{'name': 'SHR-1209', 'type': 'DRUG', 'description': 'SHR-1209，single subcutaneous injection of 450mg', 'armGroupLabels': ['Treatment group A', 'Treatment group B', 'Treatment group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230601', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}