Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT03641794
Status:
UNKNOWN
Last Update Posted:
2019-08-01
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy 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': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse events - type, incidence, severity', 'timeFrame': '28 day', 'description': 'Evaluate the safety and toxicity of DN1406131 in healthy volunteers'}, {'measure': 'Maximum Tolerated Dose', 'timeFrame': '14 day', 'description': 'To define the Maximum Tolerated Dose (MTD)'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '48 hours', 'description': 'Cmax'}, {'measure': 'Serum for biomarkers of IDO activity (kynurenine and tryptophan)', 'timeFrame': '48 hours', 'description': 'Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy.\n\nPharmacodynamics（PD）'}, {'measure': 'Elimination half-life', 'timeFrame': '48 hours', 'description': 'T1/2'}, {'measure': 'peak time', 'timeFrame': '48 hours', 'description': 'Tmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater of 18 years and less than 45\n* Weight ≥50 kg,body mass index of 19\\~26 kg/m2\n* Signed ICF\n\nExclusion Criteria:\n\n* active autoimmune disease\n* uncontrolled concurrent illness\n* Smoking\n* Drugs\n* positive serology for HIV, Hepatitis B or C,Syphilis\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03641794', 'briefTitle': 'Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangxi Qingfeng Pharmaceutical Co. Ltd.'}, 'officialTitle': 'A Phase I Study of DN1406131 in Healthy Adults', 'orgStudyIdInfo': {'id': 'DN-DN1406131-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DN1406131', 'description': '25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg', 'interventionNames': ['Drug: DN1406131']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DN1406131', 'type': 'DRUG', 'description': 'IDO1 and TDO2 inhibitor', 'armGroupLabels': ['DN1406131']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '255000', 'city': 'Zibo', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'PKUCare Luzhong Hospital', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}], 'centralContacts': [{'name': 'Wanwan Ji', 'role': 'CONTACT', 'email': 'jiwanwan@sh-qingfeng.net', 'phone': '18852605644'}, {'name': 'Shunpeng Hu', 'role': 'CONTACT', 'email': 'hushunpeng@sh-qingfeng.net', 'phone': '+86 13683002413'}], 'overallOfficials': [{'name': 'Qinghong Zhou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jiangxi Qingfeng Pharmaceutical Co. Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangxi Qingfeng Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai De Novo Pharmatech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}