protocolSection identificationModule nctId: NCT06281704, orgStudyIdInfo id: AK101-102, briefTitle: A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-26, primaryCompletionDateStruct date: 2022-05-17, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis., conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: AK101 IV, interventions name: AK101 SC, interventions name: Placebo, interventions name: AK101 IV/AK101 SC, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Elimination half-life (T1/2) of AK101, primaryOutcomes measure: Mean residence time (MRT) of AK101, primaryOutcomes measure: Area under curve (AUC) of AK101, primaryOutcomes measure: Apparent distribution volume (VD/F) of AK101, primaryOutcomes measure: Systemic clearance (CL/F) of AK101, primaryOutcomes measure: Maximum (peak) plasma concentration (Cmax) of AK101, primaryOutcomes measure: Time to maximum plasma concentration (Tmax) of AK101, secondaryOutcomes measure: Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment)., secondaryOutcomes measure: Proportion of subjects with clinical response at Week8(per the Mayo score)., secondaryOutcomes measure: Immunogenicity index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, city: Bengbu, state: Anhui, zip: 233099, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Affiliated Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, zip: 350004, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Nanfang Hospital, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Sixth Affiliated Hospital of Sun Yat-Sen University, city: Guanzhou, state: Guangdong, zip: 510665, country: China, locations facility: The Second Hospital of Hebei Medical University, city: Shijiazhuang, state: Hebei, zip: 050004, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: People's Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Nanjing First Hospital, city: Nanjing, state: Jiangsu, zip: 210012, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221004, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Shengjing Hospital of China Medical University, city: Shengyang, state: Liaoning, zip: 110000, country: China, locations facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Tianjing People's Hospital, city: Tianjing, state: Tianjing, zip: 300122, country: China, hasResults: False