Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 6:46 PM
Study NCT ID:
NCT05391360
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'From Days 1-35', 'description': 'Incidence of adverse events'}, {'measure': 'AUC', 'timeFrame': 'Day 1-12', 'description': 'Maximum plasma concentration of study drugs'}, {'measure': 'HBV DNA', 'timeFrame': 'Day 1-35', 'description': 'Change from baseline in HBV DNA'}], 'secondaryOutcomes': [{'measure': 'HBsAg', 'timeFrame': 'Day 1-35', 'description': 'Change from baseline in HBsAg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealth volunteer:\n\n1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.\n2. subjects and must be 18 to 45 years of age inclusive.\n3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\\^2, inclusive.\n4. Physical examination and vital signs without clinically significant abnormalities.\n\nPatients with chronic hepatitis B:\n\n1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.\n2. subjects and must be 18 to 65 years of age inclusive.\n3. Body mass index（BMI）between 18 and 32 kg / m\\^2, inclusive.\n4. No cirrhosis.\n\nExclusion Criteria:\n\nHealth volunteer:\n\n1. Use of \\>5 cigarettes per day during the past 3 months.\n2. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).\n3. Donation or loss of blood over 450 mL within 3 months prior to screening.\n\nPatients with chronic hepatitis B:\n\n1. AFP\\>50 ng/mL.\n2. INR\\>1.5.\n3. Positive for Viral hepatitis C, HIV and syphilis.'}, 'identificationModule': {'nctId': 'NCT05391360', 'briefTitle': 'Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Study in Healthy Subjects and Chronic Hepatitis B Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Freethiadine', 'orgStudyIdInfo': {'id': 'HEC160208-HBV-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Freethiadine tablets', 'description': 'part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg', 'interventionNames': ['Drug: Freethiadine tablets(part I)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Freethiadine placebo tablets', 'description': 'part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg', 'interventionNames': ['Drug: Freethiadine placebo tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Freethiadine tablet', 'description': 'part 2(Patients with chronic hepatitis B): There will be a total of 4 dose cohorts:100 mg、200 mg(BID or QD)、300 mg', 'interventionNames': ['Drug: Freethiadine tablets (part II)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'entecavir tablets', 'description': 'part 2(Patients with chronic hepatitis B): 0.5 mg', 'interventionNames': ['Drug: entecavir tablets']}], 'interventions': [{'name': 'Freethiadine tablets(part I)', 'type': 'DRUG', 'description': 'Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)', 'armGroupLabels': ['Freethiadine tablets']}, {'name': 'Freethiadine tablets (part II)', 'type': 'DRUG', 'description': 'once or twice daily for consecutive 28 days', 'armGroupLabels': ['Freethiadine tablet']}, {'name': 'Freethiadine placebo tablets', 'type': 'DRUG', 'description': 'Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)', 'armGroupLabels': ['Freethiadine placebo tablets']}, {'name': 'entecavir tablets', 'type': 'DRUG', 'description': 'once daily for consecutive 28 days', 'armGroupLabels': ['entecavir tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Southern Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'overallOfficials': [{'name': 'JinLin Hou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Hospital of Southern Medical University'}, {'name': 'JunQI Niu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Yanhua Ding, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}