Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT05719961
Status:
UNKNOWN
Last Update Posted:
2023-02-09
First Post:
2023-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Linear Up Log Down'}, {'measure': 'Maximum concentration（Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Observed value'}, {'measure': 'Area under the Glucose Infusion Rate (GIR) - time curve （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Maximum GIR （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Area under the Glucose Infusion Rate (GIR) - time curve （Part II）', 'timeFrame': '0h to 24 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Maximum GIR（Part II）', 'timeFrame': '0 to 24 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Time to maximum GIR （Part II）', 'timeFrame': '0 to 24 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Area under the concentration-time curve （Part II）', 'timeFrame': '0 to 120 hours after dosing', 'description': 'Linear Up Log Down'}, {'measure': 'Maximum concentration（Part II）', 'timeFrame': '0 to 120 hours after dosing', 'description': 'Observed value'}, {'measure': 'Time to maximum concentration （Part II）', 'timeFrame': '0 to 120 hours after dosing', 'description': 'Observed value'}], 'secondaryOutcomes': [{'measure': 'Time to maximum concentration （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Observed value'}, {'measure': 'Terminal half-life （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Terminal half-life of insulin aspart'}, {'measure': 'Time to maximum GIR （Part I）', 'timeFrame': '0 to 10 hours after dosing', 'description': 'Based on smoothed data'}, {'measure': 'Incidence of anti-drug antibody (ADA)（Part I）', 'timeFrame': 'from 0 hour after dosing to 3-14 days after the last dose', 'description': 'Incidence of ADA for insulin aspart'}, {'measure': 'Incidence and severity of adverse events (AEs)（Part I）', 'timeFrame': 'from screening to 3-14 days after the last dose', 'description': 'The safety of test drug will be assessed'}, {'measure': 'Incidence of anti-drug antibody (ADA)（Part II）', 'timeFrame': 'from 0 hour to 7-21 days after the last dose'}, {'measure': 'Incidence and severity of adverse events (AEs)（Part II）', 'timeFrame': 'from screening to 7-21 days after the last dose', 'description': 'The safety of test drug will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male subjects aged 18 \\~ 45 (including the boundary. value)(Part I). Subjects aged 18 \\~ 45 (including the boundary value), male or female(Part II).\n2. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator\n3. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).\n\nExclusion Criteria:\n\n1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.\n2. Have a history of hypertension.\n3. Severe systemic infectious diseases within 1 month before screening.\n4. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.\n5. Presence of any abnormal and clinically significant laboratory tests.\n6. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.\n7. Known or suspected history of drug abuse or positive urine drug screening test within screening period.\n8. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;\n9. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.'}, 'identificationModule': {'nctId': 'NCT05719961', 'briefTitle': 'Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HR20014-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INS062', 'interventionNames': ['Drug: INS062 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoRapid ®', 'interventionNames': ['Drug: Insulin Aspart']}, {'type': 'EXPERIMENTAL', 'label': 'HR20014', 'interventionNames': ['Drug: HR20014 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIAsp 30', 'interventionNames': ['Drug: Insulin Aspart 30 Injection']}], 'interventions': [{'name': 'INS062 injection', 'type': 'DRUG', 'description': 'Part I: A single dose of 1.2noml/kg is administered.', 'armGroupLabels': ['INS062']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'description': 'Part I: A single dose of 0.2U/kg is administered.', 'armGroupLabels': ['NovoRapid ®']}, {'name': 'HR20014 injection', 'type': 'DRUG', 'description': 'Part II: Ascending single doses at three dose levels', 'armGroupLabels': ['HR20014']}, {'name': 'Insulin Aspart 30 Injection', 'type': 'DRUG', 'description': 'Part II: A single dosewas administered', 'armGroupLabels': ['BIAsp 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yerong Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Sheng Feng', 'role': 'CONTACT', 'email': 'sheng.feng@hengrui.com', 'phone': '+86-0518-82342973'}, {'name': 'Hong Chen', 'role': 'CONTACT', 'email': 'hong.chen@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}