Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-06 @ 9:43 PM
Study NCT ID:
NCT05624294
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-29', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events [Safety and Tolerability]', 'timeFrame': 'Upto day 15', 'description': 'Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.'}, {'measure': 'Dose PK Parameter(C-max)', 'timeFrame': 'day 1, day 7', 'description': 'Evaluate the Peak Plasma Concentration.'}, {'measure': 'Dose PK Parameter(AUC)', 'timeFrame': 'day 1, day 7', 'description': 'Evaluate the Area under the plasma concentration versus time curve.'}], 'secondaryOutcomes': [{'measure': 'Food effect PK Parameter(C-max)', 'timeFrame': 'day 10', 'description': 'Evaluate the Peak Plasma Concentration.'}, {'measure': 'Food effect PK Parameter(AUC)', 'timeFrame': 'day 10', 'description': 'Evaluate the Area under the plasma concentration versus time curve.'}, {'measure': 'QTc analysis', 'timeFrame': 'day 1, day 7', 'description': 'analysize the plasma Concentration relevance to QTcF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult subjects of 18 years to 55 years.\n2. Weight: Male≥50kg, female≥45kg BMI: 18\\~32kg/m².\n3. In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation.\n4. Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.\n\nExclusion Criteria:\n\n1. Subjects with special dietary requirements and cannot follow a uniform diet.\n2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.\n3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.\n4. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.'}, 'identificationModule': {'nctId': 'NCT05624294', 'briefTitle': 'Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cascade Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CS0159-001A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2mg CS0159', 'description': 'One tablet daily for seven days.', 'interventionNames': ['Drug: CS0159', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4mg CS0159', 'description': 'Two tablet daily for seven days.', 'interventionNames': ['Drug: CS0159', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '6mg CS0159', 'description': 'Three tablet daily for seven days.', 'interventionNames': ['Drug: CS0159', 'Drug: Placebo']}], 'interventions': [{'name': 'CS0159', 'type': 'DRUG', 'description': 'Tablets administered orally', 'armGroupLabels': ['2mg CS0159', '4mg CS0159', '6mg CS0159']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally', 'armGroupLabels': ['2mg CS0159', '4mg CS0159', '6mg CS0159']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Xuhui Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yun Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Xuhui Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cascade Pharmaceuticals, Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}