Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 3:22 PM
Study NCT ID:
NCT05702450
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic: the maximum concentration (Cmax)', 'timeFrame': 'up to 57 days', 'description': 'Concentration and exposure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.', 'detailedDescription': 'This study includes screening and treatment and follow-up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have the ability to understand the study.\n* Voluntarily participate in the study and sign the ICF.\n* 18 years ≤ age ≤ 65 years, male and female.\n* Willing to take effective contraceptive measures during the study period.\n\nExclusion Criteria:\n\n* Plan to receive any major surgery during the study period.\n* With malignant tumors within 5 years before screening.\n* Positive results of alcohol breath test or urine drug abuse screening during screening period.\n* Any reason that the investigator believes that will prevent the subject from participating in the study.'}, 'identificationModule': {'nctId': 'NCT05702450', 'briefTitle': 'Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keymed Biosciences Co.Ltd'}, 'officialTitle': 'A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CM310-100002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P1', 'description': 'CM310, Subcutaneous', 'interventionNames': ['Biological: CM310']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group P2', 'description': 'CM310, Subcutaneous, as the parallel control group', 'interventionNames': ['Biological: CM310']}], 'interventions': [{'name': 'CM310', 'type': 'BIOLOGICAL', 'description': 'CM310 Recombinant Humanized Monoclonal Antibody Injection', 'armGroupLabels': ['Group P1', 'Group P2']}]}, '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'}}}}