Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:10 PM
Study NCT ID:
NCT04561128
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2020-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1819 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2020-08-29', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Start of Treatment to end of study (approximately 13 weeks)', 'description': 'Incidence and severity of adverse events'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics-AUC0-last', 'timeFrame': 'Start of Treatment to end of study (approximately 13 weeks)', 'description': 'Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration'}, {'measure': 'Pharmacokinetics-AUC0-inf', 'timeFrame': 'Start of Treatment to end of study (approximately 13 weeks)', 'description': 'Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration'}, {'measure': 'Pharmacokinetics-Tmax', 'timeFrame': 'Up to 13 weeks', 'description': 'Time to Cmax of SHR-1819'}, {'measure': 'Pharmacokinetics-Cmax', 'timeFrame': 'Up to 13 weeks', 'description': 'Maximum observed concentration of SHR-1819'}, {'measure': 'Pharmacokinetics-CL/F', 'timeFrame': 'Up to 13 weeks', 'description': 'Apparent clearance of SHR-1819'}, {'measure': 'Pharmacokinetics-Vz/F', 'timeFrame': 'Up to 13 weeks', 'description': 'Apparent volume of distribution during terminal phase of SHR-1819'}, {'measure': 'Pharmacokinetics-t1/2', 'timeFrame': 'Up to 13 weeks', 'description': 'Terminal elimination half-life of SHR-1819'}, {'measure': 'Change from baseline to end of treatment for TARC/CCL17', 'timeFrame': 'Up to 13 weeks', 'description': 'TARC/CCL17'}, {'measure': 'Change from baseline to end of treatment for IgE', 'timeFrame': 'Up to 13 weeks', 'description': 'IgE'}, {'measure': 'Immunogenicy of SHR-1819 after administration', 'timeFrame': 'Up to 13 weeks', 'description': 'Anti-drug antibody'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.', 'detailedDescription': 'This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.\n* Be able to comply with all the requirements and able to complete the study.\n* Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.\n* No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.\n* Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.\n\nExclusion Criteria:\n\n* Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;\n* Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study\n* Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial\n* Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response"}, 'identificationModule': {'nctId': 'NCT04561128', 'briefTitle': 'A Trial of SHR-1819 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atridia Pty Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR-1819-I-101-AUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1819', 'description': 'Experimental: SHR-1819', 'interventionNames': ['Drug: SHR-1819']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator: placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR-1819', 'type': 'DRUG', 'description': 'SHR-1819 will be subcutaneously administered with different dose levels', 'armGroupLabels': ['SHR-1819']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be subcutaneously administered with different dose levels', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Atridia Pty Limited', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atridia Pty Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}