Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-30 @ 9:16 AM
Study NCT ID:
NCT05891366
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2023-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study of WAL0921 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2023-05-20', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': 'Day 1 to Day 64'}], 'secondaryOutcomes': [{'measure': 'Number of participants with clinically significant changes in hematology lab values', 'timeFrame': 'Day 64', 'description': 'Hematology labs include complete blood count with differential and coagulation panel'}, {'measure': 'Number of participants with clinically significant changes in chemistry lab values', 'timeFrame': 'Day 64', 'description': 'Chemistry labs include a comprehensive metabolic panel'}, {'measure': 'AUC', 'timeFrame': 'Day 1 to Day 64', 'description': 'Area Under the Drug Concentration-Time Curve'}, {'measure': 'Cmax', 'timeFrame': 'Day 1 to Day 64', 'description': 'Maximum Observed Drug Concentration'}, {'measure': 'Half-life', 'timeFrame': 'Day 1 to Day 64', 'description': 'Drug terminal elimination half-life'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing\n2. Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator\n3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2\n\nExclusion Criteria:\n\n1. Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator\n2. Renal function calculated by the CKD-EPI (2021) equation with eGFR \\<90 mL/min/1.73 m2 at the time of screening\n3. Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test \\>0.30 g/g\n4. Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems'}, 'identificationModule': {'nctId': 'NCT05891366', 'briefTitle': 'Single Ascending Dose Study of WAL0921 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Walden Biosciences'}, 'officialTitle': 'Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'WAL0921-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WAL0921', 'description': 'Single intravenous infusion of investigational drug WAL0921', 'interventionNames': ['Drug: WAL0921']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single intravenous infusion of normal saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'WAL0921', 'type': 'DRUG', 'description': 'Investigational product WAL0921', 'armGroupLabels': ['WAL0921']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo product', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Pharmacology Unit', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Andrew Blair, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Walden Biosciences, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walden Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}