Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-30 @ 2:47 AM
Study NCT ID:
NCT05639803
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'receive PEGIFNα1b (day 1) to day 28', 'description': 'The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured.'}, {'measure': 'λz', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day 15.', 'description': 'Pharmacokinetic assessments'}, {'measure': 'Tmax', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day 15.', 'description': 'Pharmacokinetic assessments'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day 15.', 'description': 'Pharmacokinetic assessments'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day 15', 'description': 'Pharmacokinetic assessments'}, {'measure': 'ADA', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day21.', 'description': 'ADA in plasma of participants for immunogenicity assessments.'}, {'measure': 'Nab', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day21.', 'description': 'Nab in plasma of participants for immunogenicity assessments.'}], 'secondaryOutcomes': [{'measure': 'Level of Neopterin', 'timeFrame': 'Receive PEGIFNα1b/placebo (day 1) to day15', 'description': "Plasma concentration of 2',5'-OAS(Type I,II), Neopterin"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peginterferon α1b for Injection'], 'conditions': ['Herpes Zoster']}, 'descriptionModule': {'briefSummary': "This is a Phase I，randomized, double-blind, placebo controlled,dose escalated,single administrated clinical trial in Chinese healthy adult's volunteers.\n\nIn the trial, it is planned to enroll 50 subjects, randomized to 5 dosage groups to receive the test drug and the placebo control.", 'detailedDescription': "This study is a randomized, double-blind, placebo-controlled, dose-escalation, single-dose phase I clinical study, including safety tolerability assessment, pharmacokinetic studies and immunogenicity studies, to evaluate the expression level of mRNA in whole blood of 2',5'-oligoadenylate synthetase, as well as the level of Neopterin (NTP) in serum."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must agree to and voluntarily sign a written Informed Consent prior to the study.\n* Must be healthy males or females.\n* Between 18 to 70 years old, inclusive.\n* Must have a body mass index (BMI) of 19 to 26 kg/m2, inclusive, and male subject must have a minimum body weight of 50.0 kg,female subject must have a minimum body weight of 45kg.\n\nExclusion Criteria:\n\n* History of allergic or anaphylactic reactions or known allergy to any component of interferon medication including the study drug.\n* Having abnormality in physical examination,vital signs, electrocardiogram,eye,skin(e.g., psoriasis,sarcoidosis) within screening and the abnormality is considered clinically significant as determined by the investigator.\n* Laboratory values (platelet, hemoglobin or neutrophils)that were outside the normal range，ALT，AST or TG\\>1.5 fold normal range，positive test result for pregnancy,hepatitis B surface antigen(HBsAg) ,hepatitis C antibody (HCV Ab),treponema pallidum antibody or human immunodeficiency virus antibody(HIV Ab), thyroid function abnormal within screening.\n* Having any ischemic disease,autoimmune disease,infectious disorders,history of neuropsychiatric disease (e.g., epilepsy,depression,suicidal behavior).\n* History of any disease (gastrointestinal tract,renal,hepatic,neurologic,hematologic,endocrinologic, tumor, pulmonary, cardiovascular and/or other major disease), or organ transplantation within 6 months prior to screening.\n* Unlikely to comply with unified diet or having difficulty to swallow.\n* Treatment with any medication( prescription/nonpreserip drugs/vitamins/herbs ) within 30 days prior to screening.\n* History of alcohol abuse (more than 14 units of alcohol per week, one unit of alcohol equals 360ml beer or 150ml wine or 45ml strong drinks containing 40% alcohol) within 3 months prior to screening or a positive screen test for presence for alcohol at screening or into hospital.\n* Consuming any special diet(including dragon fruit,mango,grapefruit,etc. ) or doing strenuous exercise within 2 weeks prior to screening. Consuming alcohol or caffeine containing products(e.g., coffee,tea, coco,chocolate ) within 48 hours of dosing. Intaking any products can affecting drug absorption,distribution,excretion,metabolism.\n* Regular smoking with consumption ≥ 5 cigarettes per day winthin 3 months prior to screening.\n* Treatment with any interferon product within 6 months prior to screening.\n* Participation in any other medication or device study within 3 months prior to screening.\n* History of drug (morphine,marihuana,methamphetamine,dimethylamphetamine,ketamine,etc.) abuse or a positive screen test for presence for drugs.\n* Having donated or lost 200 mL or more of blood within 3 months prior to screening or plan to donate blood throughout the study and within 3 months after the study.\n* Lactating mothers,male subjects(or pairs) and female subjects have child-bearing/sperm or egg donation plan from 30 days before study to 3 months after study while unwill to practice effective birth control throughout the study.\n* History of blood or needle phobia.\n* Driving or operating delicated machinery throughout the study.\n* Investigator discretion as to unsuitability'}, 'identificationModule': {'nctId': 'NCT05639803', 'briefTitle': 'A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Institute Of Biological Products'}, 'officialTitle': 'A Phase I，Randomized, Double-blind，Placebo Controlled，Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults', 'orgStudyIdInfo': {'id': 'SH-002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEGIFNα1b 1.5 μg/kg', 'description': '8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered', 'interventionNames': ['Drug: PEGIFNα1b', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PEGIFNα1b 3.0 μg/kg', 'description': '8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered', 'interventionNames': ['Drug: PEGIFNα1b', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PEGIFNα1b 5.0μg/kg', 'description': '8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered', 'interventionNames': ['Drug: PEGIFNα1b', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PEGIFNα1b 6.0 μg/kg', 'description': '8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered', 'interventionNames': ['Drug: PEGIFNα1b', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PEGIFNα1b 7.0 μg/kg', 'description': '8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered', 'interventionNames': ['Drug: PEGIFNα1b', 'Drug: Placebo']}], 'interventions': [{'name': 'PEGIFNα1b', 'type': 'DRUG', 'description': '100μg/vial', 'armGroupLabels': ['PEGIFNα1b 1.5 μg/kg', 'PEGIFNα1b 3.0 μg/kg', 'PEGIFNα1b 5.0μg/kg', 'PEGIFNα1b 6.0 μg/kg', 'PEGIFNα1b 7.0 μg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.5ml/vial', 'armGroupLabels': ['PEGIFNα1b 1.5 μg/kg', 'PEGIFNα1b 3.0 μg/kg', 'PEGIFNα1b 5.0μg/kg', 'PEGIFNα1b 6.0 μg/kg', 'PEGIFNα1b 7.0 μg/kg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The first affiliated hospital of bengbu medical college', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}], 'overallOfficials': [{'name': 'Shanghai Institute Of Biological Products Co., Ltd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SINOPHARM'}, {'name': 'The first affiliated hospital of bengbu medical college', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bengbu medical college'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Institute Of Biological Products', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}