Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-01 @ 12:54 PM
Study NCT ID:
NCT06939504
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration of HRS-9813 capsule (Cmax)', 'timeFrame': 'Day 1-Day 23.'}, {'measure': 'Maximum observed concentration of HRS-9813 tablet (Cmax)', 'timeFrame': 'Day 1-Day 23.'}, {'measure': 'Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)', 'timeFrame': 'Day 1-Day 23.'}, {'measure': 'Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)', 'timeFrame': 'Day 1-Day 23.'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'Day 1-Day 23.'}, {'measure': 'Time to Cmax of HRS-9813 capsule (Tmax).', 'timeFrame': 'Day 1-Day 23.'}, {'measure': 'Time to Cmax of HRS-9813 tablet (Tmax).', 'timeFrame': 'Day 1-Day 23.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-45 years.\n2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.\n3. Subjects not with clinically significant vital signs and laboratory tests.\n4. Take contraception measures.\n\nExclusion Criteria:\n\n1. Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.\n2. Severe infection, severe trauma or major surgery.\n3. Any medications in the two weeks before screening or baseline period.\n4. History of blood donation or severe blood loss.\n5. Have been vaccinated within 2 weeks before the screening or baseline period.\n6. History of smoking or excessive alcohol or drug abuse.\n7. Other situations that the researcher judges to be unsuitable.'}, 'identificationModule': {'nctId': 'NCT06939504', 'briefTitle': 'A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'Evaluation of the Relative Bioavailability of HRS-9813 Capsule and Tablet in Healthy Subjects and the Effect of Food on the Pharmacokinetics of HRS-9813 Capsule', 'orgStudyIdInfo': {'id': 'HRS-9813-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-9813 Capsule Group', 'interventionNames': ['Drug: HRS-9813 Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-9813 Tablet Group', 'interventionNames': ['Drug: HRS-9813 Tablet']}], 'interventions': [{'name': 'HRS-9813 Capsule', 'type': 'DRUG', 'description': 'HRS-9813 capsule.', 'armGroupLabels': ['HRS-9813 Capsule Group']}, {'name': 'HRS-9813 Tablet', 'type': 'DRUG', 'description': 'HRS-9813 tablet.', 'armGroupLabels': ['HRS-9813 Tablet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}