Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05769920
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Escalation TTHX1114 Ophthalmic Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity', 'timeFrame': '28 days', 'description': 'Important Medical Events (ocular) related to study treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Epithelial Degeneration']}, 'descriptionModule': {'briefSummary': 'Dose escalation 3+3 design with accelerated titration 4 dose levels', 'detailedDescription': 'This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female or male, 18 to 65 years of age, Female subjects of child-bearing potential must be non-pregnant\n* Able to provide voluntary written informed consent\n* Normal ocular function (BCVA 20/20) and anatomy\n* Available for and agree to all study procedures including inpatient monitoring, follow-up visits, sample collection, study treatment administration\n* Body mass index 18.5 to 35 kg/m\\^2\n* Demonstrated ability to self-administer eye drops\n\nExclusion Criteria:\n\n* Clinically significant co-morbid ocular conditions\n* Co-morbid medical conditions requiring treatment\n* Active ocular infection within the 2 weeks prior to Day 1\n* Active non-ocular infection requiring antibiotics within the 2 weeks prior to Day 1\n* Use of systemic or dermatological cytotoxic chemotherapy within the 1 month prior to Day 1\n* Planned contact lens use during the study period\n* Use of any investigational product within the 1 month prior to Day 1\n* Corticosteroid use in the 1 month prior to Day 1\n* Major surgery within the 3 months prior to Day 1\n* History of dependence on alcohol or drugs of abuse\n* History of intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance\n* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study"}, 'identificationModule': {'nctId': 'NCT05769920', 'acronym': 'EPI', 'briefTitle': 'Dose Escalation TTHX1114 Ophthalmic Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trefoil Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'NM141-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTHX1114 Dose Level 1', 'description': 'TTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days', 'interventionNames': ['Drug: TTHX1114(NM141) Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'TTHX1114 Dose Level 2', 'description': 'TTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days', 'interventionNames': ['Drug: TTHX1114(NM141) Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'TTHX1114 Dose Level 3', 'description': 'TTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days', 'interventionNames': ['Drug: TTHX1114(NM141) Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'TTHX1114 Dose Level 4', 'description': 'TTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days', 'interventionNames': ['Drug: TTHX1114(NM141) Ophthalmic Solution']}], 'interventions': [{'name': 'TTHX1114(NM141) Ophthalmic Solution', 'type': 'DRUG', 'description': 'Eye drop twice daily', 'armGroupLabels': ['TTHX1114 Dose Level 1', 'TTHX1114 Dose Level 2', 'TTHX1114 Dose Level 3', 'TTHX1114 Dose Level 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Trefoil Clinical Site #132', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Thomas Tremblay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trefoil Therapeutics.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trefoil Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}