Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06938204
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2025-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Ascending Dose, Multiple Ascending Dose, Food Effect Study
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': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '8 subjects were randomized to 6 Active and 2 Placebo in each cohort.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Analysis', 'timeFrame': '7 days after last dosing', 'description': 'Adverse Events:\n\nAEs will be coded using the most current version of Medical Dictionary for Regulatory Activities® (MedDRA®). A by-subject AE data listing, including verbatim term, preferred term, treatment (INV-101 or placebo), severity, and relationship to drug, will be provided. The number of subjects experiencing treatment-emergent adverse events (TEAEs) and the number of TEAEs will be summarized by study part and treatment (INV-101 or placebo) using frequency counts.'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '3 days', 'description': 'AUC0-12, AUC0-t, AUC0-inf'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '3 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 and agree to refrain from sperm donation until 90 days after the last dosing.\n* Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.\n* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:\n\nExclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.\n5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug or study drug excipients.'}, 'identificationModule': {'nctId': 'NCT06938204', 'briefTitle': 'Single Ascending Dose, Multiple Ascending Dose, Food Effect Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovo Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'INV101-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD A', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD B', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD C', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD A', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD B', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD C', 'interventionNames': ['Drug: INV-101', 'Drug: INV-101 Placebo']}], 'interventions': [{'name': 'INV-101', 'type': 'DRUG', 'description': 'SAD MAD', 'armGroupLabels': ['MAD A', 'MAD B', 'MAD C', 'SAD A', 'SAD B', 'SAD C']}, {'name': 'INV-101 Placebo', 'type': 'DRUG', 'description': 'SAD MAD', 'armGroupLabels': ['MAD A', 'MAD B', 'MAD C', 'SAD A', 'SAD B', 'SAD C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmaron', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovo Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}