Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT05715333
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CM326 Injection 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergency adverse events during treatment', 'timeFrame': 'Up to week 12', 'description': 'By assessing the number and severity of adverse events during the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40185989', 'type': 'DERIVED', 'citation': 'Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.', 'detailedDescription': 'The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years and ≤ 65 years, healthy male.\n* With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.\n* Subjects can communicate well with investigators and comply with protocol requirements.\n\nExclusion Criteria:\n\n* Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.\n* Major surgery is planned during the study period.\n* The average daily smoking volume is more than 5 cigarettes within 3 months before screening.\n* Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.\n* There are any reasons that the investigator believes will prevent the subject from participating in the study.'}, 'identificationModule': {'nctId': 'NCT05715333', 'briefTitle': 'Study of CM326 Injection in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keymed Biosciences Co.Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CM326-100003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose', 'interventionNames': ['Biological: CM326', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose', 'interventionNames': ['Biological: CM326', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'CM326 220mg/2mL or matched placebo, subcutaneous at high dose', 'interventionNames': ['Biological: CM326', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'CM326 220mg/2mL or matched placebo, subcutaneous at medium dose', 'interventionNames': ['Biological: CM326', 'Other: Placebo']}], 'interventions': [{'name': 'CM326', 'type': 'BIOLOGICAL', 'description': 'CM326 Injection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zibo', 'country': 'China', 'facility': 'PKUCare Luzhong Hospital', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}], 'overallOfficials': [{'name': 'Jie Hou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Care Luzhong Hospital'}, {'name': 'Hong Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Care Luzhong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keymed Biosciences Co.Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}