[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599338":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":24,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Accro Bioscience (Suzhou) Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AC-101 Dose 1","EXPERIMENTAL","Participants will receive AC-101 Dose 1 as tablets orally twice daily from Week 0 through W12",[13],"Drug: AC-101",{"label":15,"type":10,"description":16,"interventionNames":17},"AC-101 Dose 2","Participants will receive AC-101 Dose 2 as tablets orally once daily from Week 0 through W12",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","AC-101","AC-101 tablets will be administered orally.",[9,15],null,[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The First Affiliated Hospital,Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"RenMao","CONTACT","+86 020-87330631","zsyyiec2020@mail.sysu.edu.cn",{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100599338","phase-1-a-study-of-ac-101-tablets-in-participants-with-moderate-to-severe-active-ulcerative-colitis-100599338",false,"NCT07083193","A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis","A Phase 1b, Multicenter, Open-label, Randomized Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of Ulcerative Colitis (UC) or suspected UC symptom for at least 3 months prior to enrolment and confirmed diagnosis of UC by endoscopic and histopathological examinations during screening.\n* Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclusive) with 3 subscores meeting the followings:\n\n  1. Stool frequency (SF) subscore of .≥ 2 points, and\n  2. Rectal bleeding (RB) subscore of .≥ 1 points, and\n  3. Endoscopic (ES) subscore of ≥ 2 points (excluding friability), confirmed by screening endoscopy\n* Disease extension of ≥ 15cm from anal verge, confirmed by screening endoscopy\n* Currently using concomitant 5-salicylates (5-ASA) or oral corticosteroid (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide MMX or equivalent) should keep stable doses from 2 weeks prior to enrolment till study completion.\n* Biologic-naïve or previous biological treatment for more than 5 half-lives.\n\nExclusion Criteria:\n\n* Previous\u002Fcurrent documented diagnosis of Crohn's Disease (CD), indeterminate colitis, severe UC required hospitalization or corticosteroid pulse therapy, ulcerative proctitis, fulminant colitis, ischemic colitis and other intestinal diseases.\n* Previous received 2 or more types of advanced treatment including biologics (e.g., TNF-α antibodies, IL-12\u002F23 antibodies, integrin-α4β7 antibodies) and small molecule (e.g., JAK inhibitors, S1P receptor modulator), and all deemed by investigator as treatment failure.\n* Intravenous\u002Frectal administration of steroids or topical administration of 5-ASA within 2 weeks prior to enrolment; systemic administration of small molecule (e.g., Tofacitinib, Upadacitinib, Ozanimod) within 4 weeks prior to enrolment.\n* Clostridium difficile infection or other enteric pathogen infection within 30 days prior to endoscopy, or positive for Clostridium difficile or other enteric pathogens prior to enrolment.","ALL","18 Years","75 Years",{"count":59,"type":60},24,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.\n\nThe total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.\n\nThe study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.",[67],"Ulcerative Colitis","2025-07-23",{"date":70,"type":71},"2025-07-24","ACTUAL",{"date":73,"type":71},"2025-01-20",{"date":75,"type":60},"2027-04-30",{"name":5,"class":6},1]