Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-08 @ 3:25 PM
Study NCT ID:
NCT06619392
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Escalation Trial of HRS-2129 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', 'interventionModelDescription': 'HRS-2129 for dose escalation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of adverse events', 'timeFrame': 'from ICF signing date to day 28 since last dose'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameter of HRS-2129: Cmax', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: AUC0-t', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: AUC0-inf', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: Tmax', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: t1/2', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: CL/F', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Pharmacokinetic parameter of HRS-2129: Vz/F', 'timeFrame': '0 hour to 216 hour after administration'}, {'measure': 'Electrocardiogram measurement: QTcF interval', 'timeFrame': '90 minute predose to 48 hour after administration'}, {'measure': 'Pain detection threshold for the Thermode Cold Test', 'timeFrame': '0 hour to 12 hour after administration'}, {'measure': 'Pain tolerance time for the Thermode Cold Test', 'timeFrame': '0 hour to 12 hour after administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18 to 55 years old (inclusive);\n2. Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 \\~ 28.0 kg/m2 (inclusive);\n3. Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose;\n4. Female subjects: non-pregnant or non-lactating;\n5. The skin to receive pain stimuli has no wound or derma disease.\n6. Subject who is willing to accept cold pain test.\n7. Subject who voluntarily signs the informed consent.\n\nExclusion Criteria:\n\n1. Subject who suffers from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities;\n2. Subject with the following abnormalities: aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatine value exceeds the upper limit of the normal range, QTcF \\> 450 ms, hyperpotassemia or hypopotassemia;\n3. Subject with a history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;\n4. Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;\n5. Subject who underwent major surgery within 6 months prior to screening, or received surgery that may significantly affect the pharmacokinetics or safety evaluation of the IMP, or who plans to undergo surgery during the study period;\n6. Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration;\n7. Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study;\n8. Subject who used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or who plans to receive other drug treatments during the study;\n9. Subject who has participated in clinical trials and received experimental drugs within 3 months before screening, or plans to participate in other clinical trials during this study;\n10. Donate blood/blood loss ≥ 400 mL within 3 months before screening;\n11. Subject who smoked more than 5 cigarettes per day on average within 3 months before screening;\n12. Drink more than 14 units of alcohol per week on average;\n13. Drink excessive tea, coffee or caffeinated beverages within 3 months before screening;\n14. Consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration;\n15. Subject who has special requirements for diet and cannot follow a unified diet;\n16. Subject with clinical significant abnormalities in medical examination;\n17. Subject with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody;\n18. Subject with a history of drug abuse or with a positive result for drug abuse test;\n19. Alcohol test result is positive;\n20. Subject who has difficulty in swallowing, or venous blood collection, or who cannot tolerate venipuncture, or who has a history of fainting of needle or blood;\n21. Subject may not be able to complete the study due to other reasons or the investigators considers that he is not suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT06619392', 'briefTitle': 'A Single Dose Escalation Trial of HRS-2129 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of HRS-2129 and the Food Effect on Pharmacokinetics Following Single Dose Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HRS-2129-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment at dose level 1', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment at dose level 2', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment at dose level 3', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment at dose level 4', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment at dose level 5', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 Placebo']}], 'interventions': [{'name': 'HRS-2129', 'type': 'DRUG', 'description': 'HRS-2129', 'armGroupLabels': ['Treatment at dose level 1', 'Treatment at dose level 2', 'Treatment at dose level 3', 'Treatment at dose level 4', 'Treatment at dose level 5']}, {'name': 'HRS-2129 Placebo', 'type': 'DRUG', 'description': 'HRS-2129 Placebo', 'armGroupLabels': ['Treatment at dose level 1', 'Treatment at dose level 2', 'Treatment at dose level 3', 'Treatment at dose level 4', 'Treatment at dose level 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}