Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-12 @ 12:41 AM
Study NCT ID:
NCT04097405
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind, placebo controlled'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of subjects with treatment related adverse events as assessed', 'timeFrame': 'Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)', 'description': 'Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs'}], 'secondaryOutcomes': [{'measure': 'Time to observed Cmax (Tmax)for D-0120', 'timeFrame': 'Timeframe: Day 1-Day7', 'description': 'Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax'}, {'measure': 'Area under the plasma concentration-time curve (AUC) for D-0120', 'timeFrame': 'Day 1-Day 7', 'description': 'Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of D-0120', 'timeFrame': 'Day 1-Day 7', 'description': 'Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be medically documented as healthy at physical examination\n* Moderate smokers or non-smokers\n* Subjects must be between the ages of 18 and 60\n* Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)\n* Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females\n* Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater\n* Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration\n* Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration\n* Subjects must have a complete blood count and platelet count within the normal range\n* Subjects must have a normal urinalysis\n* Subjects must have a normal estimated glomerular filtration rate\n* Subjects must have a normal ECG\n* Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures\n* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration\n\nExclusion Criteria:\n\n* Subjects with any history or clinical manifestations of disorders\n* Subjects who have any history or suspicion of kidney stones\n* Subjects who are HIV, Hep B or Hep C positive\n* History of significant allergic reactions to any drug\n* Clinically significant ECG abnormalities\n* History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening\n* Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1\n* Positive urine drug screen, alcohol breath at screening\n* Subjects had undergone major surgery within 3 months\n* Women who are pregnant or breastfeeding\n* History of significant alcohol abuse\n* Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.\n* Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk\n* Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose\n* Donation of plasma within 7 days prior to dosing'}, 'identificationModule': {'nctId': 'NCT04097405', 'briefTitle': 'Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'InventisBio Co., Ltd'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'IBIO-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'D-0120 Dose Ascending Cohorts 1-4', 'description': 'D-0120 dose daily for up to 7 days.', 'interventionNames': ['Drug: D-0120']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Dose Ascending Cohorts 1-4', 'description': 'Placebo dose daily for up to 7 days', 'interventionNames': ['Drug: Placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'D-0120/Uric Acid Lowering Agent Cohort 6', 'description': 'D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy', 'interventionNames': ['Drug: D-0120']}], 'interventions': [{'name': 'D-0120', 'type': 'DRUG', 'description': 'Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo', 'armGroupLabels': ['D-0120 Dose Ascending Cohorts 1-4', 'D-0120/Uric Acid Lowering Agent Cohort 6']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo', 'armGroupLabels': ['Placebo Dose Ascending Cohorts 1-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33163', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Syneos Health', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InventisBio Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}