Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT06350812
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2024-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile', 'timeFrame': 'From the first dose (Day 1 ) of study drug until 20 week', 'description': 'Cmax'}, {'measure': 'Pharmacokinetic profile', 'timeFrame': 'From the first dose (Day 1 ) of study drug until 20 week', 'description': 'Tmax'}, {'measure': 'Pharmacokinetic profile', 'timeFrame': 'From the first dose (Day 1 ) of study drug until 20 week', 'description': 'area under the curve0(AUC0)-tau'}, {'measure': 'Pharmacokinetic profile', 'timeFrame': 'From the first dose (Day 1 ) of study drug until 20 week', 'description': 'AUC0-last'}, {'measure': 'Effectiveness index', 'timeFrame': 'week 20', 'description': 'Change in body weight from baseline'}, {'measure': 'Effectiveness index', 'timeFrame': 'week 20', 'description': 'Proportion of participants with ≥5% weight loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.', 'detailedDescription': 'The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. The study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug，8 patients receive placebo) Subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Chinese male or female subjects aged 18-60 years (both inclusive).\n2. Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)\n\n ≥30.0 kg/m2 at screening.\n3. Weight change \\<5% in the past 3 months before screening.\n\nExclusion Criteria:\n\n1. Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes\n2. FPG \\<3.9 mmol/L at screening and/or a history of hypoglycemia.\n3. History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.\n4. Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction\n5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) , medullary thyroid carcinoma (MTC) or Category 4 and above thyroid nodules by Thyroid ultrasound Chinese Ultrasound Thyroid Imaging Reporting and Data System （C-TIRADS）\n6. Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening\n7. Systolic blood pressure \\> 160 mmHg and/or diastolic blood pressure \\> 100 mmHg at screening or randomization.\n8. Time history from the starting point of P-wave to the starting point of QRS wave（PR intervals ）\\> 210 msec and/or QRS complex（QRS） \\> 120 msec and/or Corrected QT Interval（QTcF） \\> 450 msec at screening or randomization.\n9. Serum amylase or lipase \\> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.\n10. Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.\n11. Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening\n12. History of bariatric surgery for weight loss before screening."}, 'identificationModule': {'nctId': 'NCT06350812', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'PegBio Co., Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects', 'orgStudyIdInfo': {'id': 'PB119110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PB-119', 'description': 'PB-119 administered on the first day of week 1-20 according to the dose-escalation design', 'interventionNames': ['Drug: PB-119']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo administered on the first day of week 1-20 according to the dose-escalation design', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PB-119', 'type': 'DRUG', 'description': 'Administered subcutaneously once a week', 'armGroupLabels': ['PB-119']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously once a week', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third XIANGYA Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Guoping Yang, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Xiangya Hospital of Central South University'}, {'name': 'Ping Jin, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PegBio Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}