Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04971512
Status:
TERMINATED
Last Update Posted:
2022-02-14
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Due to adverse safety signals in Part 1 (HV)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measured by adverse events', 'timeFrame': 'Up to 8 Days in HV SAD Cohorts'}, {'measure': 'Safety measured by adverse events', 'timeFrame': 'Up to 21 Days in HV MAD Cohorts'}, {'measure': 'Safety measured by adverse events', 'timeFrame': 'Up to 70 Days in NUC-suppressed CHB MAD Cohorts'}, {'measure': 'Safety measured by adverse events', 'timeFrame': 'Up to 98 Days in Viremic CHB MAD Cohorts'}], 'secondaryOutcomes': [{'measure': 'Cmax of EDP-721', 'timeFrame': 'Up to 6 Days in HV SAD Cohorts'}, {'measure': 'AUC of EDP-721', 'timeFrame': 'Up to 6 Days in HV SAD Cohorts'}, {'measure': 'Cmax of EDP-721', 'timeFrame': 'Up to 18 Days in HV MAD Cohorts'}, {'measure': 'AUC of EDP-721', 'timeFrame': 'Up to 18 Days in HV MAD Cohorts'}, {'measure': 'Cmax of EDP-721 alone and in combination with EDP-514', 'timeFrame': 'Up to 28 Days in All CHB MAD Cohorts'}, {'measure': 'AUC of EDP-721 alone and in combination with EDP-514', 'timeFrame': 'Up to 28 Days in All CHB MAD Cohorts'}, {'measure': 'Cmax of EDP-514 in combination with EDP-721', 'timeFrame': 'Up to 28 Days in All CHB MAD Cohorts'}, {'measure': 'AUC of EDP-514 in combination with EDP-721', 'timeFrame': 'Up to 28 Days in All CHB MAD Cohorts'}, {'measure': 'Change from baseline in HBV DNA Viral Load Assay', 'timeFrame': 'Through Day 28 in All CHB MAD Cohorts'}, {'measure': 'Change from baseline in quantitative HBsAg', 'timeFrame': 'Through Day 28 in All CHB MAD Cohorts'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['First-in-Human', 'Single Ascending Dose', 'Multiple Ascending Dose', 'Hepatitis B virus', 'HBV'], 'conditions': ['Chronic Hepatitis B Virus Infection']}, 'descriptionModule': {'briefSummary': 'Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.\n\nPart 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Part 1 (HV Population):\n\nInclusion Criteria:\n\n* An informed consent document signed and dated by the subject.\n* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.\n\nExclusion Criteria:\n\n* Clinically relevant evidence or history of illness or disease.\n* Pregnant or nursing females.\n* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.\n* A positive urine drug screen at screening or Day -1.\n* Current tobacco smokers or use of tobacco within 3 months prior to screening.\n* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).\n* History of regular alcohol consumption.\n* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.\n\nPart 2 (CHB Population)\n\nInclusion Criteria (Nuc-Suppressed CHB Population)\n\n* An informed consent document signed and dated by the subject.\n* Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive\n* HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.\n* HBV DNA levels:\n\n * A Screening HBV DNA level in serum/plasma that is \\<LLOQ and\n * No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)\n* CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening\n\nInclusion Criteria (Viremic CHB Population):\n\n* An informed consent document signed and dated by the subject.\n* Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive\n* HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.\n* HBV DNA levels:\n\n * For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or\n * For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and\n * For all subjects, no HBV DNA serum/plasma test values \\<1,000 IU/ml over the previous 12 months (using an approved test)\n* CHB subjects must not have been on prescribed anti-HBV treatment, specifically pegIFN and/or NUC therapy for at least 12 months prior to Screening\n\nExclusion Criteria (Nuc-Suppressed and Viremic CHB Population):\n\n* A documented prior diagnosis of cirrhosis\n* Pregnant or nursing females\n* Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV\n* Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases'}, 'identificationModule': {'nctId': 'NCT04971512', 'briefTitle': 'A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enanta Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)', 'orgStudyIdInfo': {'id': 'EDP 721-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDP-721 HV SAD Cohorts', 'description': 'EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration', 'interventionNames': ['Drug: EDP-721']}, {'type': 'EXPERIMENTAL', 'label': 'EDP-721 HV MAD Cohorts', 'description': 'EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days', 'interventionNames': ['Drug: EDP-721']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'EDP-721 HV SAD Placebo Cohort', 'description': 'Matching placebo, in one single administration', 'interventionNames': ['Drug: Placebo (Part 1)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'EDP-721 HV MAD Placebo Cohort', 'description': 'Matching placebo, once daily for 14 days', 'interventionNames': ['Drug: Placebo (Part 1)']}, {'type': 'EXPERIMENTAL', 'label': 'EDP-721+ EDP-514 HBV MAD Cohorts', 'description': 'EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days', 'interventionNames': ['Drug: EDP-721 (Part 2)', 'Drug: EDP-514']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'EDP-721+ EDP-514 HBV MAD Placebo Cohorts', 'description': 'Matching placebo once daily for 42 days', 'interventionNames': ['Drug: Placebo (Part 2)']}], 'interventions': [{'name': 'EDP-721', 'type': 'DRUG', 'description': 'Oral administration (Part 1)', 'armGroupLabels': ['EDP-721 HV MAD Cohorts', 'EDP-721 HV SAD Cohorts']}, {'name': 'Placebo (Part 1)', 'type': 'DRUG', 'description': 'Placebo to match EDP-721, oral administration (Part 1)', 'armGroupLabels': ['EDP-721 HV MAD Placebo Cohort', 'EDP-721 HV SAD Placebo Cohort']}, {'name': 'EDP-721 (Part 2)', 'type': 'DRUG', 'description': 'Oral administration (Part 2)', 'armGroupLabels': ['EDP-721+ EDP-514 HBV MAD Cohorts']}, {'name': 'Placebo (Part 2)', 'type': 'DRUG', 'description': 'Placebo to match EDP-721 (Part 2)', 'armGroupLabels': ['EDP-721+ EDP-514 HBV MAD Placebo Cohorts']}, {'name': 'EDP-514', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['EDP-721+ EDP-514 HBV MAD Cohorts']}, {'name': 'Placebo (Part 2)', 'type': 'DRUG', 'description': 'Placebo to match EDP-514', 'armGroupLabels': ['EDP-721+ EDP-514 HBV MAD Placebo Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research Ltd', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Enanta Pharmaceuticals, Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Enanta Pharmaceuticals, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enanta Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}