Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT02746302
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2016-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events (TEAEs)', 'timeFrame': 'From baseline up to 72 hours after single dose'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma HS-20004 concentration versus time curve', 'timeFrame': 'From time 0 to 72 hours after single dose'}, {'measure': 'Peak Plasma Concentration (Cmax) after dose', 'timeFrame': 'From time 0 to 72 hours after single dose'}, {'measure': 'Terminal elimination half-life (t½) for HS-20004', 'timeFrame': 'From time 0 to 72 hours after single dose'}, {'measure': '24-hour profiles of plasma glucose and serum insulin', 'timeFrame': 'From time 0 to 24 hours after single dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in China. The aim of this trial is to assess the safety and tolerability of HS-20004 in healthy Chinese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) between 19 and 24 kg/m\\^2， inclusive， and a total body weight of at least 50 kg;\n\nExclusion Criteria:\n\n* Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator\n* Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol\n* Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, or serious unconscious hypoglycemia Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive\n* History of drug or alcohol abuse within 6 months before randomization\n* Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization\n* Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization\n* Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks of randomization\n* Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials in the near year, or had blood donation/loss \\>400mL within 3 months\n* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration Subject who is unsuitable for inclusion in the study in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT02746302', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'HS-20004-Ia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-20004', 'description': 'One dose of HS-20004(0.02,0.04,0.05,0.06,0.08,0.1mg) Injected s.c. (under the skin) once for one subject.', 'interventionNames': ['Drug: HS-20004']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Injected s.c. (under the skin) once for one subject.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HS-20004', 'type': 'DRUG', 'armGroupLabels': ['HS-20004']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}