Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT04224857
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2019-05-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'matching placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study participants will be randomized to either receive AMT-101 or placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of anti-drug antibodies against AMT-101', 'timeFrame': '14 days', 'description': 'Incidence of anti-drug antibodies against AMT-101 in healthy adult volunteers and subjects with UC.'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent adverse events (safety and tolerability)', 'timeFrame': '14 days', 'description': 'Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (CMax)', 'timeFrame': '14 days', 'description': 'To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.'}, {'measure': 'Pharmacodynamics', 'timeFrame': '14 days', 'description': 'To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.', 'detailedDescription': 'A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.\n\nSubjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.\n\nPatients may be\n\n1. naïve to anti-TNFα therapy or\n2. have failed or demonstrated intolerance to anti-TNF-α therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy Male Volunteers for Single Dose portion only', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPART A (Healthy Volunteers)\n\n* Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening\n* Between 18 and 45 years of age, inclusive.\n* Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).\n\nPART B (Adult Ulcerative Colitis)\n\n* Male and Female patients 18 years and older\n* Documented diagnosis of UC for at least 3 months duration\n* Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:\n* Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)\n\nExclusion Criteria:\n\nPART A and PART B\n\n* Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.\n* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).\n\nPART B\n\n* Clinical findings of Crohn's disease\n* A prior history of surgery for UC\n* Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus"}, 'identificationModule': {'nctId': 'NCT04224857', 'acronym': 'AURIGA1', 'briefTitle': 'SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Molecular Transport'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101', 'orgStudyIdInfo': {'id': 'AMT-101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMT-101', 'description': 'AMT-101', 'interventionNames': ['Drug: AMT-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'AMT-101', 'type': 'DRUG', 'otherNames': ['no other name applicable'], 'description': 'Single or daily dosing at doses A, B, C, D, E, F', 'armGroupLabels': ['AMT-101']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['no other name applicable'], 'description': 'Single or daily dosing at doses A, B, C, D, E, F', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LLC ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'ICS ARENSIA Exploratory Medicine SRL', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Medical Center of Harmoniya krasy, Department of clinical trials', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Bittoo Kanwar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Applied Molecular Transport'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Molecular Transport', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}