Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05503693
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2022-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability, and Pharmacokinetics Study of AP303 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Dose and Food Effect Safety Outcome Measures', 'timeFrame': 'From baseline to Day 14 (Day 29 for Food Effect)', 'description': 'Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes'}, {'measure': 'Multiple Dose Safety Outcome Measures', 'timeFrame': 'From baseline to Day 28', 'description': 'Incidence and severity of AEs, laboratory, ECG, and vital sign changes.'}, {'measure': 'Cmax after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'Tmax after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'AUC0-last after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'AUC0-inf after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 't1/2 after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'CL/F after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'Ae and CLR (if warranted) after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'V/F after single dose', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'PK characteristics after single dose'}, {'measure': 'Cmax after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'Tmax after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'AUC0-τ after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'Cav after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 't1/2 after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'Rac after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'Ae and CLR (if warranted) after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'V/F after multiple dose', 'timeFrame': 'Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14', 'description': 'PK characteristics after multiple dose'}, {'measure': 'Ctrough after multiple dose', 'timeFrame': 'Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13', 'description': 'PK characteristics after multiple dose'}], 'secondaryOutcomes': [{'measure': 'Effect of Food on the single dose Cmax', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose Tmax', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose AUC0-last', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose AUC0-inf', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose t1/2', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose CL/F', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose Ae and CLR (if warranted)', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}, {'measure': 'Effect of Food on the single dose V/F', 'timeFrame': 'Pre-dose to 96 hours post-dose', 'description': 'Effect of food on the single dose PK'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.', 'detailedDescription': 'The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and female subjects, 18 to 55 years of age, inclusive.\n2. Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.\n3. Female subjects of child-bearing potential must have a negative pregnancy test result and agree to use highly effective contraception consisting of two forms of birth control\n4. Subjects and their partners of childbearing potential must use two medically approved methods of contraception and the subjects should refrain from sperm/egg donation for the duration of the study and for 3 months after drug administration\n\nExclusion Criteria:\n\n1. Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.\n2. History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.\n3. People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).\n4. History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.\n5. Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).\n6. Received an investigational drug within 30 days or 5 xT1/2 whichever is longer prior to the first dose of our study for small molecule; or within 90 days or 5 x T1/2 whichever is longer prior to the first dose of our study drug; or device study within 90 days prior to screening or more than 4 times per year.\n7. History of drug and/or alcohol abuse or addiction.\n8. Use of \\>5 cigarettes or equivalent nicotine-containing product per day.'}, 'identificationModule': {'nctId': 'NCT05503693', 'briefTitle': 'A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alebund Pharmaceuticals'}, 'officialTitle': 'A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AP303-PK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AP303', 'description': 'AP303', 'interventionNames': ['Drug: AP303 50 μg', 'Drug: AP303 150 μg', 'Drug: AP303 300 μg', 'Drug: AP303 600 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo 50 μg', 'Drug: Placebo 150 μg', 'Drug: Placebo 300 μg', 'Drug: Placebo 600 μg']}], 'interventions': [{'name': 'AP303 50 μg', 'type': 'DRUG', 'description': 'AP303 tablet', 'armGroupLabels': ['AP303']}, {'name': 'AP303 150 μg', 'type': 'DRUG', 'description': 'AP303 tablet', 'armGroupLabels': ['AP303']}, {'name': 'AP303 300 μg', 'type': 'DRUG', 'description': 'AP303 tablet', 'armGroupLabels': ['AP303']}, {'name': 'AP303 600 μg', 'type': 'DRUG', 'description': 'AP303 tablet', 'armGroupLabels': ['AP303']}, {'name': 'Placebo 50 μg', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo 150 μg', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo 300 μg', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo 600 μg', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network Pty Ltd', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Sam Francis, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nucleus Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alebund Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}