Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 10:08 PM
Study NCT ID:
NCT06548932
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AE)', 'timeFrame': 'From Predose to Day14 after a single dose', 'description': 'Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.'}], 'secondaryOutcomes': [{'measure': 'GIRmax', 'timeFrame': 'From 0 hours to 24 hours after a single dose', 'description': 'Maximum glucose infusion rate'}, {'measure': 'AUCGZR33,0-24 h', 'timeFrame': 'From Predose to Day8 after a single dose', 'description': 'Area under the plasma concentration curve of GZR33 from 0 to 24 hours'}, {'measure': 'AUCIAsp，0-12 h', 'timeFrame': 'From 0 hours to 12 hours after a single dose', 'description': 'Area under the plasma concentration curve of insulin aspart from 0 to 12 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Voluntarily participated in the study and signed the informed consent form (ICF);\n* 2\\. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;\n* 3.Body mass index \\[BMI= weight (kg)/height (m) 2\\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；\n\nExclusion Criteria:\n\n* 1\\. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;\n* 2\\. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;\n* 3\\. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;\n* 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;\n* 5\\. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.'}, 'identificationModule': {'nctId': 'NCT06548932', 'briefTitle': 'A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gan and Lee Pharmaceuticals, USA'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult Subjects', 'orgStudyIdInfo': {'id': 'GL-GZR-CH1006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GZR33 Injection', 'description': 'Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)', 'interventionNames': ['Drug: GZR33 Injection', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GZR101 Injection', 'description': 'Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)', 'interventionNames': ['Drug: GZR101 Injection', 'Drug: Placebo']}], 'interventions': [{'name': 'GZR33 Injection', 'type': 'DRUG', 'description': 'A single dose', 'armGroupLabels': ['GZR33 Injection']}, {'name': 'GZR101 Injection', 'type': 'DRUG', 'description': 'A single dose', 'armGroupLabels': ['GZR101 Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A single dose', 'armGroupLabels': ['GZR101 Injection', 'GZR33 Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Study Site 01', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], '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'}}}}