Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 12:19 PM
Study NCT ID:
NCT06828393
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of S-1117
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'To assess the maximum serum concentration (CMAX)', 'timeFrame': '2 months'}, {'measure': 'To assess time to reach maximum serum concentration (tMAX)', 'timeFrame': '2 months'}, {'measure': 'To assess elimination half-life (t1/2)', 'timeFrame': '2 months'}, {'measure': 'To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)', 'timeFrame': '2 months'}, {'measure': 'To assess clearance (CL)', 'timeFrame': '2 months'}, {'measure': 'To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)', 'timeFrame': '2 months'}, {'measure': 'To assess bioavailability after SC administration (F%)', 'timeFrame': '2 months'}, {'measure': 'To characterize absolute and proportional change from baseline of immunoglobulin G (IgG) at multiple timepoints', 'timeFrame': '2 months'}, {'measure': 'Incidence and characterization of antidrug antibody (ADA)', 'timeFrame': '2 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of S-1117 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Is available for the entire duration of the study and follow up.\n2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).\n4. Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.\n5. Is in good physical and mental health in the opinion of the Investigator or delegate.\n\nMajor Exclusion Criteria:\n\n1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.\n2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.\n3. Has a known immunodeficiency disorder.\n4. Has a history of malignancy other than non-melanoma skin cancer.\n5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.\n6. Has positive laboratory evidence for active hepatitis at screening.\n7. Has received a live vaccine within 2 months of Screening.\n8. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.\n\nOther inclusion/exclusion eligibility criteria apply.'}, 'identificationModule': {'nctId': 'NCT06828393', 'briefTitle': 'A Phase 1 Study of S-1117', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seismic Therapeutic AU Pty Ltd'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'S-1117-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1117 Part 1: Single ascending dose (SAD) cohorts', 'interventionNames': ['Drug: S-1117', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'S-1117 Part 2: Multiple ascending dose (MAD) cohorts', 'interventionNames': ['Drug: S-1117', 'Other: Placebo']}], 'interventions': [{'name': 'S-1117', 'type': 'DRUG', 'description': 'S-1117 via subcutaneous or intravenous administration.', 'armGroupLabels': ['S-1117 Part 1: Single ascending dose (SAD) cohorts', 'S-1117 Part 2: Multiple ascending dose (MAD) cohorts']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo via subcutaneous or intravenous administration.', 'armGroupLabels': ['S-1117 Part 1: Single ascending dose (SAD) cohorts', 'S-1117 Part 2: Multiple ascending dose (MAD) cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'CMAX Contact', 'role': 'CONTACT', 'email': 'cmax@cmax.com.au', 'phone': '1800 150 433'}], 'facility': 'CMAX Clinical Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'Seismic Contact', 'role': 'CONTACT', 'email': 'clinical@seismictx.com', 'phone': '1800 244 475'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seismic Therapeutic AU Pty Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avance Clinical Pty Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}