Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04527718
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C071192', 'term': 'entacapone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With TEAEs', 'timeFrame': 'up to 71days (90 days for Cohorts 1 and 2)', 'description': 'Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.'}], 'secondaryOutcomes': [{'measure': 'PK', 'timeFrame': 'up to 71days (90 days for Cohorts 1 and 2)', 'description': 'PK parameters not limit to Cmax'}, {'measure': 'Incidence of immunogenicity', 'timeFrame': 'up to 71days (90 days for Cohorts 1 and 2)', 'description': 'ADA, and NAbs if ADA is positive'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.', 'detailedDescription': 'Total duration of the study period per subject is about 4 months broken down as follows:\n\nThe screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand and willing to sign the ICF\n2. Healthy male and female subjects, non-smokers, 18-55 years of age\n3. In the opinion of the investigator, with no significant medical history, and in good health.\n4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.\n5. Subjects are able to follow the study protocol and complete the trial.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to similar drugs to 611 or their excipients.\n2. Pregnant, or nursing females.\n3. HepBsAg or HepCAb positive.\n4. Human immunodeficiency virus (HIV) positive.\n5. Positive urine drug screen, or cotinine test.\n6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.'}, 'identificationModule': {'nctId': 'NCT04527718', 'briefTitle': 'Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.'}, 'officialTitle': 'A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': 'SSGJ-611-HV-I-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '611 dose 1 (45mg) plus placebo', 'interventionNames': ['Drug: Placebo', 'Drug: 611']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '611 dose 2 (150mg) plus placebo', 'interventionNames': ['Drug: Placebo', 'Drug: 611']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '611 dose 3 (300mg) plus placebo', 'interventionNames': ['Drug: Placebo', 'Drug: 611']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '611 dose 4 (450mg) plus placebo', 'interventionNames': ['Drug: Placebo', 'Drug: 611']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': '611 dose 5 (600mg) plus placebo', 'interventionNames': ['Drug: Placebo', 'Drug: 611']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo as a single SC injection on Day 1;', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}, {'name': '611', 'type': 'DRUG', 'description': '611 as a single SC injection on Day 1;', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Dallas Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}