Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 3:34 PM
Study NCT ID:
NCT05147259
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
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': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'from Day1 to Day15', 'description': 'The incidence of adverse events will be collected and the safety of HR011408 will be assessed'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'Maximum observed concentration (Cmax)'}, {'measure': 'Time to maximum observed concentration (Tmax)', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'Time to maximum observed concentration (Tmax)'}, {'measure': 'Elimination half-life (t1/2)', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'Elimination half-life (t1/2)'}, {'measure': 'Time to 50% maximum observed concentration (time to 50% Cmax)', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'Time to 50% maximum observed concentration (time to 50% Cmax)'}, {'measure': 'Onset of appearance', 'timeFrame': 'from 0 to 10 hours after dose administration', 'description': 'First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)'}], 'secondaryOutcomes': [{'measure': 'Assessment of development of Anti-drug Antibodies (ADAs)', 'timeFrame': 'from Day1 to Day15 after dose administration', 'description': 'Incidence of Anti-drug Antibodies (ADAs) will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes in Adults']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent\n2. Body mass index 18.0-26.0kg/m2(both inclusive)\n3. Body weight ≥50.0kg(male),≥45.0kg(female)\n4. Fasting serum/plasma glucose \\<6.1mmol/L\n\nExclusion Criteria:\n\n1. Known or suspected of being allergic to any ingredient in the study drug.\n2. Participated in any drug or medical device-related clinical trial within 3 months before screening.\n3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration\n4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.\n5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.'}, 'identificationModule': {'nctId': 'NCT05147259', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject', 'orgStudyIdInfo': {'id': 'HR011408-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort one: Low dose', 'description': 'Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively', 'interventionNames': ['Drug: HR011408 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort two: Medium dose', 'description': 'Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively', 'interventionNames': ['Drug: HR011408 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort three: high dose', 'description': 'Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively', 'interventionNames': ['Drug: HR011408 injection']}], 'interventions': [{'name': 'HR011408 injection', 'type': 'DRUG', 'description': 'Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.', 'armGroupLabels': ['Cohort one: Low dose', 'Cohort three: high dose', 'Cohort two: Medium dose']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sheng Feng, Ph.D.', 'role': 'CONTACT', 'email': 'Sheng.feng@hengrui.com', 'phone': '+86-0518-82342973'}, {'name': 'Yifan Li', 'role': 'CONTACT', 'email': 'yifan.li@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}