Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-27 @ 12:52 PM
Study NCT ID:
NCT06135168
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C562190', 'term': 'polyethylene glycol-recombinant human growth hormone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-12', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-drug antibody (Number of Participants with positive ADA)', 'timeFrame': '0 hours -168 hours'}], 'primaryOutcomes': [{'measure': 'Pharmacokinetics (Peak Plasma Concentration (Cmax)) of PEG-rhGH with present and new preparation', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Pharmacokinetics (The area under the concentration time curve from time zero to time infinity(AUC0-∞)) of PEG-rhGH with present and new preparation', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Pharmacokinetics (the area under the concentration-time curve from time zero to time t (AUC0-t))of PEG-rhGH with present and new preparation', 'timeFrame': '0 hours -168 hours'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (the time to reach the peak drug concentration(Tmax) of PEG-rhGH with present and new preparation.', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Pharmacokinetics (half-life (t1/2)) of PEG-rhGH with present and new preparation.', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Pharmacokinetics (terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation.', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Safety and tolerability （Number of participants with treatment-related adverse events）', 'timeFrame': '0 hours -168 hours'}, {'measure': 'Safety and tolerability (Number of Participants with Abnormal Laboratory Values and/or Vital Signs That Are Related to Treatment)', 'timeFrame': 'Day1 0 hours and Day 8 168 hours'}, {'measure': 'Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)', 'timeFrame': 'Day1 0 hours and Day 8 168 hours'}, {'measure': 'Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)', 'timeFrame': 'Day1 0 hours and Day 8 168 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Growth Hormone Deficiency (PGHD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male aged ≥18 years old and≤45 years old;\n* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;\n* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.\n\nExclusion Criteria:\n\n* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;\n* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;\n* Subjects with severe infection, severe trauma, or major surgery prior to screening;\n* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;\n* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);\n* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.'}, 'identificationModule': {'nctId': 'NCT06135168', 'briefTitle': 'A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Open-label, Parallel Study to Compare the Pharmacokinetics of Two Polyethylene Glycol Recombinant Human Growth Hormone With Different Preparations by Single Subcutaneous Injection in Chinese Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': 'GenSci004-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-rhGH with new preparation', 'interventionNames': ['Drug: PEG-rhGH with new preparation']}, {'type': 'EXPERIMENTAL', 'label': 'PEG-rhGH with present preparation', 'interventionNames': ['Drug: PEG-rhGH with present preparation']}], 'interventions': [{'name': 'PEG-rhGH with new preparation', 'type': 'DRUG', 'description': 'A single subcutaneous injection of PEG-rhGH with new preparation', 'armGroupLabels': ['PEG-rhGH with new preparation']}, {'name': 'PEG-rhGH with present preparation', 'type': 'DRUG', 'description': 'A single subcutaneous injection of PEG-rhGH with present preparation', 'armGroupLabels': ['PEG-rhGH with present preparation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu Xinhua Hospital affiliated to North Sichuan Medical College', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}