Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT05043792
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metabolite characterization in plasma and estimation', 'timeFrame': '14 days', 'description': 'observed drug-related material in plasma to determine the presence of any metabolite \\>10%'}, {'measure': 'Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL)', 'timeFrame': '14 days', 'description': 'cGMP: cyclic guanosine monophosphate'}, {'measure': 'Utilization of PGx results', 'timeFrame': '14 days', 'description': 'A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response'}], 'primaryOutcomes': [{'measure': 'Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]', 'timeFrame': '14 days', 'description': '* TEAE: Treatment emergent adverse events\n* Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)', 'timeFrame': '14 days'}, {'measure': 'Maximum observed plasma concentration at steady state (Cmax, ss)', 'timeFrame': '14 days'}, {'measure': 'Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)', 'timeFrame': '14 days'}, {'measure': 'Minimum observed plasma concentration at steady state (Cmin, ss)', 'timeFrame': '14 days'}, {'measure': 'Trough plasma concentration (Ctrough)', 'timeFrame': '14 days'}, {'measure': 'Accumulation ratio (Rac)', 'timeFrame': '14 days'}, {'measure': 'Average concentration (Cav)', 'timeFrame': '14 days'}, {'measure': 'Volume of distribution at steady state (Vz/F, ss)', 'timeFrame': '14 days'}, {'measure': 'Clearance at steady state (CL/F, ss)', 'timeFrame': '14 days'}, {'measure': 'Half-life at steady state (T1/2, ss)', 'timeFrame': '14 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained\n* Age ≥ 18.0 years and ≤ 55.0 years, male or female\n* BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg\n* No clinically significant findings in medical examination\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to lactose\n* Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration\n* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality\n* HbA1c \\> 5.7 % at Screening\n* Subject with a history of severe visual diseases; or visual changes\n* Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded'}, 'identificationModule': {'nctId': 'NCT05043792', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransThera Sciences (Nanjing), Inc.'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TT00920US03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 1 (Low dose)', 'description': 'TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.', 'interventionNames': ['Drug: TT-00920']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 2 (High dose)', 'description': 'TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.', 'interventionNames': ['Drug: TT-00920']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.', 'interventionNames': ['Drug: TT-00920 Placebo']}], 'interventions': [{'name': 'TT-00920', 'type': 'DRUG', 'description': 'TT-00920 Tablets', 'armGroupLabels': ['Dose 1 (Low dose)', 'Dose 2 (High dose)']}, {'name': 'TT-00920 Placebo', 'type': 'DRUG', 'description': 'TT-00920 Placebo Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmaron CPC, Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransThera Sciences (Nanjing), Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}