Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT06858657
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2024-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects
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': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number and severity of treatment emergent adverse events (TEAEs)', 'timeFrame': '7 days after single dose and 3 days after the first dose of multiple doses', 'description': 'To assess the safety and tolerability of single or multiple oral dose of HSK44459 in healthy adult volunteers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSK44459', 'healthy subjects', 'phase1'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK44459 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;\n2. 18 years to 55 years (inclusive), male and female;\n3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 19-26 kg/m2 (inclusive) ;\n4. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.\n\nExclusion Criteria:\n\n1. Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;\n2. Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;\n3. Have a history of any malignant tumors;\n4. The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;\n5. Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;\n6. Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;\n7. Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;\n8. Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening, or positive urine drug screen at screening;\n9. Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice;\n10. Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;\n11. Subjects who have a allergic to any component of HSK44459 or allergic history to opiates;\n12. Have participated in any clinical investigator within 3 months prior to screening;\n13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;\n14. Not suitable for this study as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT06858657', 'briefTitle': 'A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK,PD and Food Effect of HSK44459 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HSK44459-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK4449', 'description': 'Single or multiple oral doses of HSK44459, and food effect of HSK44459', 'interventionNames': ['Drug: HSK44459']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single or multiple oral doses of placebo, and food effect of placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'HSK44459', 'type': 'DRUG', 'description': 'Dose 1 to Dose 5', 'armGroupLabels': ['HSK4449']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'dose 1 to dose 5', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}