Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 9:44 AM
Study NCT ID:
NCT07081503
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of ADX-626 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of ADX-626 in Healthy Participants', 'timeFrame': 'Day 1 to Day 365', 'description': 'Incidence, relationship and severity of adverse events and serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of ADX-626 - Maximum Concentration', 'timeFrame': 'Day 1 to Day 29', 'description': 'Cmax'}, {'measure': 'Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration', 'timeFrame': 'Day 1 to Day 29', 'description': 'Tmax'}, {'measure': 'Pharmacokinetics (PK) of ADX-626 - Exposure', 'timeFrame': 'Day 1 to Day 29', 'description': 'Area Under the Curve (AUC)'}, {'measure': 'Pharmacodynamics (PD) of ADX-626 - Factor XI', 'timeFrame': 'Day 1 to Day 365', 'description': 'Change from baseline in Factor XI measurements'}, {'measure': 'Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time', 'timeFrame': 'Day 1 to Day 365', 'description': 'Change from baseline in Activated Partial Thromboplastin Time (aPTT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Participants']}, 'descriptionModule': {'briefSummary': 'This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).', 'detailedDescription': 'A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age 18 to 45 years at the time of informed consent\n* Males or women of non-childbearing potential (WONCBP)\n* Willing to comply with all study requirements while participating\n* Suitable venous access for blood sampling.\n* Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg/m2\n* Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters\n* Willing to use acceptable contraception methods if applicable\n\nKey Exclusion Criteria:\n\n* Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer\n* History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.\n* Current infection\n* Participation in an interventional drug study within the last 90 days'}, 'identificationModule': {'nctId': 'NCT07081503', 'acronym': 'ADX-626-101', 'briefTitle': 'Phase 1 Study of ADX-626 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADARx Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants', 'orgStudyIdInfo': {'id': 'ADX-626-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX-626', 'interventionNames': ['Drug: ADX-626']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ADX-626', 'type': 'DRUG', 'description': 'siRNA duplex oligonucleotide', 'armGroupLabels': ['ADX-626']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 1YR', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Richmond Pharmacology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 1YR', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ulrike Lorch, MD', 'role': 'CONTACT', 'email': 'volunteer@richmondpharmacology.com', 'phone': '44 20 7042 5800'}, {'name': 'Ulrike Lorch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Richmond Pharmacology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Lisa A Melia', 'role': 'CONTACT', 'email': 'lmelia@adarx.com', 'phone': '858-333-9022'}], 'overallOfficials': [{'name': 'Aditya Patel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADARx Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADARx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}