Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT06049095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Cmax'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Area under the concentration curve from 0 to last (AUC0-last)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Area under the concentration curve from 0 to infinity (AUC0-inf)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Time of the maximum observed plasma concentration (tmax)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Elimination rate constant (λz)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Terminal elimination half-life (t1⁄2)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Concentration at 12 hours (C12)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Oral clearance (CL/F)'}, {'measure': 'To further characterize the PK of LTG-001 in healthy participants', 'timeFrame': 'Up to 10 days of dosing', 'description': 'Oral apparent volume of distribution (Vz/F)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.\n* Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.\n* Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).\n\nExclusion Criteria:\n\n* Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption\n* Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study\n* Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use\n* Donation of over 500 mL blood ≤ 3 months prior to start of participation\n* Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study\n* Participant is under legal custodianship."}, 'identificationModule': {'nctId': 'NCT06049095', 'briefTitle': 'A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Latigo Biotherapeutics'}, 'officialTitle': 'A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age', 'orgStudyIdInfo': {'id': 'LTG-001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTG-001', 'description': 'Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts', 'interventionNames': ['Drug: LTG-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LTG-001', 'type': 'DRUG', 'description': 'Oral doses', 'armGroupLabels': ['LTG-001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral doses', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Clinical Research Unit', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latigo Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}