protocolSection identificationModule nctId: NCT06389942, orgStudyIdInfo id: 9MW3011-2022-CP101, briefTitle: Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mabwell (Shanghai) Bioscience Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objectives of the study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: 9MW3011, interventions name: 9MW3011 placebo, outcomesModule primaryOutcomes measure: Adverse Event(including serious adverse event), secondaryOutcomes measure: Number of subjects with abnormal vital signs, secondaryOutcomes measure: Number of subjects with abnormal clinically significant results from physical examination, secondaryOutcomes measure: Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters, secondaryOutcomes measure: Number of subjects with abnormal clinically significant clinical laboratory results, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: λz, secondaryOutcomes measure: t1/2z, secondaryOutcomes measure: Vz, secondaryOutcomes measure: CL, secondaryOutcomes measure: MRT, secondaryOutcomes measure: Pharmacodynamic(PD)parameters-hepcidin, secondaryOutcomes measure: PD parameters-serum iron, secondaryOutcomes measure: PD parameters-TSAT, secondaryOutcomes measure: Anti-drug antibodies(ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PKUcare Luzhong Hospital, city: Zibo, state: Shandong, country: China, geoPoint lat: 36.79056, lon: 118.06333, hasResults: False