Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:57 AM
Study NCT ID:
NCT06548906
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GZR4 Injection at Different Injection Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-672h', 'timeFrame': 'From Predose to 672 hours after a single dose', 'description': 'Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours'}], 'secondaryOutcomes': [{'measure': 'AUC0-∞', 'timeFrame': 'From Predose to 672 hours after a single dose', 'description': 'Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity'}, {'measure': 'Cmax', 'timeFrame': 'From Predose to 672 hours after a single dose', 'description': 'Maximum Concentration of GZR4 Injection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.\n* 2\\. A Male adult subjects aged 18-55 years old.\n* 3\\. Body mass index (BMI) between 19.0-24.0 kg/m2\n\nExclusion Criteria:\n\n* 1\\. Known or suspected hypersensitivity to investigational medical product(s) or related products.\n* 2\\. Participation in a clinical study of another study drug within 3 months prior to randomization.\n* 3\\. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.\n* 4\\. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening\n* 5\\. More than 14 units of alcohol per week within 3 months prior to randomization\n* 6\\. Smoking more than 5 cigarettes per day within 3 months prior to randomization'}, 'identificationModule': {'nctId': 'NCT06548906', 'briefTitle': 'A Study of GZR4 Injection at Different Injection Sites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gan and Lee Pharmaceuticals, USA'}, 'officialTitle': 'A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GZR4-T2D-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GZR4 Injection- Abdomen', 'description': 'Participants received GZR4 Injection by subcutaneous injection on Abdomen.', 'interventionNames': ['Drug: GZR4 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'GZR4 Injection- Upper Arm', 'description': 'Participants received GZR4 Injection by subcutaneous injection on Upper Arm.', 'interventionNames': ['Drug: GZR4 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'GZR4 Injection- Thigh', 'description': 'Participants received GZR4 Injection by subcutaneous injection on Thigh.', 'interventionNames': ['Drug: GZR4 Injection']}], 'interventions': [{'name': 'GZR4 Injection', 'type': 'DRUG', 'description': 'GZR4 Injection administered sc, once weekly.', 'armGroupLabels': ['GZR4 Injection- Abdomen', 'GZR4 Injection- Thigh', 'GZR4 Injection- Upper Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Study Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'wei zhao, PhD', 'role': 'CONTACT', 'email': 'wei.zhao@ganlee.com', 'phone': '01056456746'}], 'overallOfficials': [{'name': 'Clinical Transparency', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gan & Lee Pharmaceuticals.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gan and Lee Pharmaceuticals, USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}