Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-26 @ 3:16 AM
Study NCT ID:
NCT07223333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2025-10-29', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety -- 1A', 'timeFrame': '29 days', 'description': 'Incidence and severity (using CTCAE version 5.0.) of treatment-emergent AEs and SAEs and evaluation of pharmacokinetic data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'insulin resistance'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of Part 1 of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: Single Ascending Dose Inclusion criteria\n\n 1. Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF);\n 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;\n 3. Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening;\n 4. In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1);\n 5. Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug;\n 6. Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and\n 7. Willing to comply with all study procedures and requirements throughout the duration of the study.\n\nExclusion Criteria:\n\n1. Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary.\n2. Liver function tests (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], alkaline phosphatase \\[ALP\\], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements \\>1.5 × ULN; b. For ALP, measurements \\>2 × ULN; or c. For total bilirubin, measurements \\>1.5 × ULN.\n3. Estimated glomerular filtration rate £60 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1);\n4. Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH \\<1 × lower limit of normal \\[LLN\\] or TSH \\>1 × ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test.\n5. History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;\n6. Personal or family history of long QT syndrome;\n7. Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic) deemed to be exclusionary, as judged by the Investigator;\n8. Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate \\<40 bpm or \\>100 bpm; b. Systolic BP \\<90 mmHg or \\>140 mmHg; or c. Diastolic BP \\<50 mmHg or \\>90 mmHg.\n9. Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval \\>450 ms for males and \\>470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion;\n10. Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening;\n11. Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in \\>3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol);'}, 'identificationModule': {'nctId': 'NCT07223333', 'briefTitle': 'A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AdipoPharma LLC'}, 'officialTitle': 'First-in-Human, Randomized, Double-Blind, Placebo-Controlled, 2-Part Study of Single Ascending Doses in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of PATAS', 'orgStudyIdInfo': {'id': 'PATAS-CL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy subjects, Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Subjects, Active', 'interventionNames': ['Drug: PATAS Trifluoroacetate']}], 'interventions': [{'name': 'PATAS Trifluoroacetate', 'type': 'DRUG', 'description': 'A drug targeting the interaction between the ALMS1 protein and alpha-PKC', 'armGroupLabels': ['Healthy Subjects, Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Excipient only formulation, without active compound', 'armGroupLabels': ['Healthy subjects, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmaology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Tarek Hiwot, M.D.', 'role': 'CONTACT', 'email': 'tarek.hiwot@adipopharma.us', 'phone': '44 7391 537 158'}, {'name': 'Michael J Fare', 'role': 'CONTACT', 'email': 'michael.fare@adipopharma.us', 'phone': '203-671-4351'}], 'overallOfficials': [{'name': 'Vincent Marion, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'AdipoPharma LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This data is confidential.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdipoPharma LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}