Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT05328557
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of subjects with Treatment Emergent Adverse Events', 'timeFrame': 'Up to 10 weeks', 'description': 'To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics profile of CUG252 (AUC)', 'timeFrame': 'Up to 10 weeks', 'description': 'To assess the Area under the plasma concentration versus time curve (AUC)'}, {'measure': 'Pharmacokinetics profile of CUG252 (Cmax)', 'timeFrame': 'Up to 10 weeks', 'description': 'To assess the maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics profile of CUG252 (Tmax)', 'timeFrame': 'Up to 10 weeks', 'description': 'To assess the time of maximum concentration (Tmax)'}, {'measure': 'Pharmacokinetics profile of CUG252 (t1/2)', 'timeFrame': 'Up to 10 weeks', 'description': 'To assess the half-life (t1/2)'}, {'measure': 'Immunogenicity of CUG252', 'timeFrame': 'Up to 10 weeks', 'description': 'To measure the serum concentration of antibodies against CUG252'}, {'measure': 'Change in the number and percentages of immune cells', 'timeFrame': 'Up to 10 weeks', 'description': 'To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.', 'detailedDescription': 'This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For healthy subject cohorts,\n\nInclusion Criteria:\n\n* Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.\n* Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray\n\nExclusion Criteria:\n\n* Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment\n* Laboratory test results outside the local reference range and deemed clinically significant\n* History of chronic medications, immunosuppressant or steroids\n* History of malignant neoplasm\n* History of relevant atopy\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation.\n* Excessive xanthine consumption\n* History of drug or alcohol addiction or dependence within 1 year\n* Positive of a tuberculosis test or a history of tuberculosis\n* Abnormal blood pressure and/or ECG parameters\n* Any prescribed medications within 28 days or nonprescription drugs within 7 days\n* Previously received aldesleukin or any other IL-2 derivative'}, 'identificationModule': {'nctId': 'NCT05328557', 'briefTitle': 'A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cugene Inc.'}, 'officialTitle': 'Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.', 'orgStudyIdInfo': {'id': 'CUG252-P101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CUG252', 'description': 'Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.', 'interventionNames': ['Drug: CUG252']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CUG252', 'type': 'DRUG', 'description': 'CUG252 will be administered by subcutaneous (SC) injection', 'armGroupLabels': ['CUG252']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered by subcutaneous (SC) injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Altasciences Clinical Kansas, Inc.', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Martin K Kankam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altasciences Company Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cugene Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}