Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT07264335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast).', 'timeFrame': 'Day 1 - Day 71.'}, {'measure': 'Peak concentration (Cmax)', 'timeFrame': 'Day 1 - Day 71.', 'description': 'Pharmacokinetic parameters of multiple-site subcutaneous injection of SHR-1819.'}], 'secondaryOutcomes': [{'measure': 'SHR-1819 Anti-Drug Antibodies (ADA)', 'timeFrame': 'Day1; Day22 ; Day43; Day71.'}, {'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Day 1 - Day 71.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, parallel-group, open-label Phase I clinical trial designed to compare the bioavailability and safety of subcutaneous SHR-1819 injection administered via different injection devices in healthy subjects.'}, '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 ≥19.0 kg/m2 and \\<26.0 kg/m2, weight of male must≥ 50.0 kg and \\<80.0 kg;\n4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 3 months after the last 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: (1) Receipt of a live-attenuated vaccine within 1 month prior to screening or planned receipt during the study; (2) Previous participation in a clinical trial involving any investigational product (drug or device) within 3 months before screening; (3) History of food or drug allergy or atopic allergic disease (asthma, urticaria);\n2. Any one of the following tests at Screening period or Baseline period: (1) Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; (2) Exclude individuals who have experienced severe trauma or undergone major surgery within the past 6 months, or who plan to undergo surgery during the trial period;\n3. General situation: (1) Have a history of drug use or drug abuse; (2) Investigators, site staff, or any other individuals directly involved in the conduct of the protocol;\n4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.'}, 'identificationModule': {'nctId': 'NCT07264335', 'briefTitle': 'A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Open-Label, Parallel-Group Clinical Study to Evaluate the Bioavailability and Safety of Subcutaneous SHR-1819 Injection Administered Using Different Injection Devices in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR-1819-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prefilled Syringe (PFS) Group', 'interventionNames': ['Drug: SHR-1819 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Artificial Intelligence (AI) Group', 'interventionNames': ['Drug: SHR-1819 Injection']}], 'interventions': [{'name': 'SHR-1819 Injection', 'type': 'DRUG', 'description': 'SHR-1819 injection.', 'armGroupLabels': ['Artificial Intelligence (AI) Group', 'Prefilled Syringe (PFS) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Zhaoyi Yang', 'role': 'CONTACT', 'email': 'young2382@ustc.edu.cn', 'phone': '+86-0551-65997421'}, {'name': 'Zhaoyi Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of University of Science and Technology of China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Yanli Dong, Ph.D', 'role': 'CONTACT', 'email': 'yanli.dong@hengrui.com', 'phone': '+86-0518-82342973'}, {'name': 'Yang Yang', 'role': 'CONTACT', 'email': 'yang.yang.yy8@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}