Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05005520
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2021-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of DTRI-031 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded, placebo-controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of a single dose of investigational drug or placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as assessed by adverse events (AEs)', 'timeFrame': 'From dosing (DTRI-031 or placebo) to final visit (Day 28)', 'description': 'Incidence of treatment-emergent AEs'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics as measured by DTRI-031 plasma levels', 'timeFrame': 'From dosing to 24 hours after dosing', 'description': 'Plasma concentration of DTRI-031 (after single dose of drug)'}, {'measure': 'Plasma von Willebrand Factor (vWF) levels', 'timeFrame': 'From dosing to 24 hours after dosing', 'description': 'Level of vWF following single administration of drug'}, {'measure': 'Platelet Function', 'timeFrame': 'From dosing to 24 hours after dosing', 'description': 'Whole blood platelet function closure times'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Pharmacokinetics', 'Pharmacodynamics']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031', 'detailedDescription': 'Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort.\n\nSubjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28.\n\nA Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years of age\n* Ability to provide written consent\n* Weight 50-110 kg with BMI 18.5-32 kg/m2\n* Willingness to use contraceptives\n* Negative COVID-19 test\n* Negative results for alcohol and drugs of abuse\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy\n* Females with active menstruation on day of dosing\n* Use of prescription medications known to affect platelet function\n* Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing\n* Contraindication to anticoagulation or increased bleeding risks\n* History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease\n* History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months\n* Planned surgery during the study\n* Any clinical significant abnormality at screening\n* Use of investigational drug in past 30 days or 5 half lives\n* Concurrent enrollment in another clinical study or more than 3 clinical studies in past 12 months\n* Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test'}, 'identificationModule': {'nctId': 'NCT05005520', 'briefTitle': 'Study of DTRI-031 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basking Biosciences, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Single-Center, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of Intravenous DTRI-031 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BB-CLIN-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Single ascending dose DTRI-031', 'description': 'Drug: DTRI-031 Single doses of DTRI-031 delivered via intravenous injection. Ascending dose levels will be evaluated.', 'interventionNames': ['Drug: DTRI-031']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Single Dose Placebo', 'description': 'Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DTRI-031', 'type': 'DRUG', 'description': 'Investigational drug', 'armGroupLabels': ['Active Comparator: Single ascending dose DTRI-031']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to DTRI-031', 'armGroupLabels': ['Placebo Comparator: Single Dose Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basking Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}