Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT07301333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of adverse events', 'timeFrame': 'from ICF signing date to Day 14 or Day 21 or Day 27'}], 'secondaryOutcomes': [{'measure': 'AUC of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 'Cmax of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 'Tmax of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 't1/2 of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 'CL/F of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 'Vz/F of HRS-6257', 'timeFrame': '0 hour to 72 hour after administration'}, {'measure': 'Pain tolerance time for the Cold Pain Test', 'timeFrame': 'Day 1 to Day 1 or Day 14'}, {'measure': 'Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses', 'timeFrame': 'from ICF signing date to Day 14'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.\n2. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².\n3. Female subjects must be non-pregnant or non-childbearing potential;\n4. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.\n\nExclusion Criteria:\n\n1. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;\n2. Known or suspected hypersensitivity to trial product(s) or related products;\n3. 12-lead ECG demonstrating QTcF \\>450 msec or history or risk factors for QT prolongation;\n4. Blood donation of more than 200 mL within the last 6 months\n5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;\n6. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.\n7. Previous administration with an investigational product (drug or vaccine) within 3 months;'}, 'identificationModule': {'nctId': 'NCT07301333', 'briefTitle': 'A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HRS-6257-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-6257 group', 'interventionNames': ['Drug: HRS-6257']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'HRS-6257', 'type': 'DRUG', 'description': 'HRS-6257', 'armGroupLabels': ['HRS-6257 group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Guoping Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Saiying Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yuanyuan Huang', 'role': 'CONTACT', 'email': 'yuanyuan.huang@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}