Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-04-09 @ 10:17 PM
Study NCT ID:
NCT07232758
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of any adverse events', 'timeFrame': 'Evaluation was performed up to the seventh day / the 16th day'}], 'secondaryOutcomes': [{'measure': 'Tmax (Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'Cmax(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'AUC0-t(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'AUC0-∞(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 't1/2(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'CLz(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'Vz(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'Ae0-t(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'Fe0-t(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'CLr(Pharmacokinetic Parameters after a Single Dose)', 'timeFrame': 'Evaluation was performed up to the third day'}, {'measure': 'Tmax(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'Cmin,ss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'Cmax,ss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'Cav(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'AUC0-t,ss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'AUC0-τ,ss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'AUC0-∞,ss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 't1/2(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'CLss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'Vss(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'Rac(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}, {'measure': 'DF(Pharmacokinetic Parameters after Multiple Doses)', 'timeFrame': 'Evaluation was performed up to the 12th day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chinese Healthy Adult Subjects']}, 'descriptionModule': {'briefSummary': 'This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and female subjects, aged 18 to 45 years.\n2. Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).\n3. Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.\n4. Voluntarily provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.\n2. History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).\n3. Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).\n4. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.\n5. Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).\n6. Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).\n7. Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.\n8. Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.\n9. History of major surgery within the past 3 months or planned surgery during the study period.\n10. Participation in another clinical trial within the past 3 months.\n11. Significant blood loss, blood donation, or transfusion within the past 3 months.\n12. History of excessive alcohol consumption or unwillingness to abstain during the study.\n13. History of heavy smoking or unwillingness to abstain during the study.\n14. History of drug abuse or positive drug screening test.\n15. Inability to tolerate venous access or history of fainting during blood draws.\n16. Inability to comply with the standardized diet provided during the study.\n17. Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT07232758', 'briefTitle': 'Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration', 'orgStudyIdInfo': {'id': 'HRS-2183-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A:HRS-2183', 'interventionNames': ['Drug: HRS-2183']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group B:placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HRS-2183', 'type': 'DRUG', 'description': 'HRS-2183', 'armGroupLabels': ['Treatment group A:HRS-2183']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Treatment group B:placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250100', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuguo Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Zhao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuanyuan Huang', 'role': 'CONTACT', 'email': 'yuanyuan.huang@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}