Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT05347758
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
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']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'HRS-7535 tablet compared with placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse Events', 'timeFrame': 'Day-2 to last follow-up', 'description': 'Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Cmax', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Maximum observed concentration (Cmax);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Tmax', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Time to maximum observed concentration (Tmax);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - t1/2', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Terminal elimination half-life (t1/2)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - CL/F', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Apparent clearance (CL/F);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Vz/F', 'timeFrame': 'pre-dose to 96 hours post-dose', 'description': 'Apparent volume of distribution (Vz/F);'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss', 'timeFrame': 'pre-last dose to 96 hours post- last dose', 'description': 'Area under the plasma concentration-time curve from time zero to tau at steady state (AUC0-τ,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'AUC0-t at steady state (AUC0-t,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'AUC0-∞ at steady state (AUC0-∞,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'Tmax at steady state (Tmax,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss', 'timeFrame': 'pre- last doseto 96 hours post- last dose', 'description': 'Cmax at steady state (Cmax,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'Ctrough at steady state (Ctrough,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'Cavg at steady state (Cavg,ss)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - DF', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'Degree of fluctuation at steady state (DF)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'Vz/F at steady state (Vz,ss/F)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - CLss/F', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 'CL/F at steady state (CLss/F)'}, {'measure': 'Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss', 'timeFrame': 'pre- last dose to 96 hours post- last dose', 'description': 't1/2 at steady state (t1/2,ss)'}, {'measure': 'Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose', 'timeFrame': 'pre-dose to 24 hours post-dose'}, {'measure': 'Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin', 'timeFrame': 'pre-dose to 24 hours post-dose'}, {'measure': 'Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide', 'timeFrame': 'pre-dose to 24 hours post-dose'}, {'measure': 'Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon', 'timeFrame': 'pre-dose to 24 hours post-dose'}, {'measure': 'Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine', 'timeFrame': 'pre-dose up to 96 hours after the last dose'}, {'measure': 'PD profile of multiple doses of HRS-7535 - HbA1c', 'timeFrame': 'pre-dose up to 96 hours after the last dose'}, {'measure': 'PD profile of multiple doses of HRS-7535 - 5-points glucose profile', 'timeFrame': 'pre-dose up to 24 hours after the last dose'}, {'measure': 'PD profile of multiple doses of HRS-7535 - weight', 'timeFrame': 'pre-dose up to 96 hours after the last dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;\n2. Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);\n3. Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;\n4. Able and willing to provide written informed consent and to comply with the study protocol;\n5. Physical examination, vital signs are normal or are judged not clinically significant by the investigator;\n\nExclusion Criteria:\n\n1. Participants with any abnormal results and judged clinically significant by the investigator;\n2. HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;\n3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;\n4. Abnormal ECG that is clinically significant, or QTcF \\>450 msec;\n5. Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;\n6. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;\n7. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;\n8. History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;\n9. Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;\n10. Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;\n11. Subject who received bariatric surgery or procedures, or use of weight-reducing drugs within 3 months prior to administration, or body weight change of more than ±10% within 3 months prior to administration;\n12. Use any drugs that may affect glucose metabolism were used within 1 month before administration.\n13. Suspected allergy to any ingredient in the study drug;\n14. Participation in clinical trials of any drug or medical device within 3 months before screening;\n15. History of regular alcohol consumption exceeding 14 drinks per week within 6 months before screening;\n16. More than 5 cigarettes per day or cigarettes within 3 months before screening;\n17. Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment;\n18. Strenuous exercise in 48 hours before treatment;\n19. Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;\n20. Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug;\n21. Subjects can't tolerate venipuncture;\n22. Subjects have special dietary requirements and cannot comply with the unified diet;\n23. Other conditions judged by the investigator to be not suitable to participate in the trial;"}, 'identificationModule': {'nctId': 'NCT05347758', 'briefTitle': 'A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HRS-7535-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Drug: HRS-7535', 'interventionNames': ['Drug: HRS-7535']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Drug: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HRS-7535', 'type': 'DRUG', 'description': 'Drug: HRS-7535', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drug: Placebo', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yimei Xu', 'role': 'CONTACT', 'email': 'yimei.xu@hengrui.com', 'phone': '0518-82342973'}, {'name': 'Shujin Cheng', 'role': 'CONTACT', 'email': 'shujin.cheng@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}