Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-31 @ 4:22 PM
Study NCT ID:
NCT04271592
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Adverse Events', 'timeFrame': 'Up to Day 10'}, {'measure': 'Number of Participants with One or More Related Adverse Events', 'timeFrame': 'Up to Day 10'}, {'measure': 'Number of Participants with One or More Severe (Grade ≥3) Adverse Events', 'timeFrame': 'Up to Day 10'}], 'secondaryOutcomes': [{'measure': 'SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'MAD Cohorts 8-10: AUC of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5'}, {'measure': 'MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5'}, {'measure': 'MAD Cohorts 8-10: Tmax of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5'}, {'measure': 'MAD Cohorts 8-10: t1/2 of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5'}, {'measure': 'Single Dose Cohorts 11-12: AUC of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'Single Dose Cohorts 11-12: Cmax of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'Single Dose Cohorts 11-12: Tmax of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}, {'measure': 'Single Dose Cohorts 11-12: t1/2 of ABI-H3733', 'timeFrame': 'before and at pre-specified time points up to 120 hours after dosing'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.\n\nExclusion Criteria:\n\n* Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.\n* History of or current persistent drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT04271592', 'briefTitle': 'A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Assembly Biosciences'}, 'officialTitle': 'A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ABI-H3733-101'}, 'secondaryIdInfos': [{'id': 'U1111-1246-2965', 'type': 'OTHER', 'domain': 'World Health Organization'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form', 'description': 'A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.', 'interventionNames': ['Drug: ABI-H3733 Liquid Oral Dosage Form']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: SAD Cohorts 1-7 Placebo Liquid Form', 'description': 'A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.', 'interventionNames': ['Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form', 'description': 'Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.', 'interventionNames': ['Drug: ABI-H3733 Liquid Oral Dosage Form']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: MAD Cohorts 8-10 Placebo Liquid Form', 'description': 'Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.', 'interventionNames': ['Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form', 'description': 'A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.', 'interventionNames': ['Drug: ABI-H3733 Solid Oral Dosage Form']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form', 'description': 'A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.', 'interventionNames': ['Drug: Placebo to ABI-H3733 Solid Oral Dosage Form']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form', 'description': 'A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.', 'interventionNames': ['Drug: ABI-H3733 Solid Oral Dosage Form']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Single Dose Fed Cohort 12 Placebo Solid Form', 'description': 'A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.', 'interventionNames': ['Drug: Placebo to ABI-H3733 Solid Oral Dosage Form']}], 'interventions': [{'name': 'ABI-H3733 Liquid Oral Dosage Form', 'type': 'DRUG', 'description': 'ABI-H3733 liquid oral dosage form', 'armGroupLabels': ['Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form', 'Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form']}, {'name': 'ABI-H3733 Solid Oral Dosage Form', 'type': 'DRUG', 'description': 'ABI-H3733 solid oral dosage form', 'armGroupLabels': ['Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form', 'Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form']}, {'name': 'Placebo to ABI-H3733 Liquid Oral Dosage Form', 'type': 'DRUG', 'description': 'Placebo to ABI-H3733 liquid oral dosage form', 'armGroupLabels': ['Part 1: MAD Cohorts 8-10 Placebo Liquid Form', 'Part 1: SAD Cohorts 1-7 Placebo Liquid Form']}, {'name': 'Placebo to ABI-H3733 Solid Oral Dosage Form', 'type': 'DRUG', 'description': 'Placebo to ABI-H3733 solid oral dosage form', 'armGroupLabels': ['Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form', 'Part 2: Single Dose Fed Cohort 12 Placebo Solid Form']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Clinical Studies', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Katia Alves, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assembly Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assembly Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}