Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-30 @ 5:00 AM
Study NCT ID:
NCT05021666
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2021-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The Investigator and other members of staff involved with the study will remain blinded to the treatment randomization code during the assembly procedure. The placebo solution will be identical in appearance to the PB-718.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'In Part A, 48 subjects will be studied in 6 groups (Groups A1 to A6), with each group consisting of 8 subjects.\n\nIn Part B, 32 subjects will be studied in 4 groups (Groups B1 to B4), with each group consisting of 8 subjects Following review of the safety, tolerability, and PK data, additional dose groups may be added to the study. Up to 3 further groups of 8 subjects (6 PB-718: 2 placebo) may be included in each of Parts A and B.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.', 'description': 'Incidence, causality, and severity of AE. The condition of each subject will be monitored from the time of signing the ICF to Final Discharge from the study. Subjects will be observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects will also be encouraged to spontaneously report AEs occurring at any other time during the study.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile', 'timeFrame': 'From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.', 'description': 'AUC (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration) from time zero to the time of the last quantifiable concentration (AUC0-tlast)'}, {'measure': 'Pharmacokinetic (PK) profile', 'timeFrame': 'From Group A1 until Group B4.The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.', 'description': 'Cmax (maximum observed plasma concentration)'}, {'measure': 'Pharmacokinetic (PK) profile', 'timeFrame': 'From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.', 'description': 'Tmax (time of the maximum observed plasma concentration)'}, {'measure': 'Pharmacokinetic (PK) profile', 'timeFrame': 'From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.', 'description': 'terminal disposition phase rate constant (λz)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.', 'detailedDescription': 'A Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB-718 following subcutaneous administration in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.\n2. Males or females, of any race, between 18 and 55 years of age, inclusive.\n3. Male subjects will weigh at least 50 kg, and female subjects will weigh at least 45 kg. Body mass index between 20.0 and 30.0 kg/m2 (Part A) or 25.0 to 50.0 kg/m2 (Part B), inclusive.\n4. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \\[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\\] is not acceptable) at Screening and Check-in/predose as assessed by the Investigator (or designee).\n\nExclusion Criteria:\n\n1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular or other heart disease, gastrointestinal, urinary/prostatic, neurological, respiratory, endocrine, or psychiatric disorder, or glaucoma, as determined by the Investigator (or designee).\n2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n3. Liver disease or liver injury, as indicated by abnormal liver function tests (e.g. serum bilirubin, direct bilirubin, ALT, AST, γ-GT, or ALK exceeding the ULN) at Screening or Baseline which may be repeated for confirmation per the Investigators discretion at Screening and Check-in.\n4. History of multiple endocrine neoplasia type 2 or an abnormal thyroid function test (thyroid stimulating hormone, triiodothyronine, thyroxine) at Screening or Baseline.\n5. Fasting plasma glucose greater than ≥126 mg/dL at Baseline.\n6. Hemoglobin A1c value \\>6.5%\n7. History of chronic or acute pancreatitis, or amylase or lipase exceeding 2 × ULN at Screening or Baseline. -"}, 'identificationModule': {'nctId': 'NCT05021666', 'briefTitle': 'A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study', 'organization': {'class': 'OTHER', 'fullName': 'PegBio Co., Ltd.'}, 'officialTitle': 'A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB-718 Following Subcutaneous Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PB718-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A1', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group A2', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group A3', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group A4', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group A5', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group A6', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group B1', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group B2', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group B3', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}, {'type': 'EXPERIMENTAL', 'label': 'Group B4', 'description': 'PB-718 vs placebo', 'interventionNames': ['Drug: Placebo', 'Drug: PB 718']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['Group A1', 'Group A2', 'Group A3', 'Group A4', 'Group A5', 'Group A6', 'Group B1', 'Group B2', 'Group B3', 'Group B4']}, {'name': 'PB 718', 'type': 'DRUG', 'description': 'dose in the next group will be determined following a review of data from the previous group', 'armGroupLabels': ['Group A1', 'Group A2', 'Group A3', 'Group A4', 'Group A5', 'Group A6', 'Group B1', 'Group B2', 'Group B3', 'Group B4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Hugh Coleman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daytona Beach CRU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PegBio Co., Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}