protocolSection identificationModule nctId: NCT06302374, orgStudyIdInfo id: GR2001-001, briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-04, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Genrix (Shanghai) Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects., conditionsModule conditions: Tetanus, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 202, type: ACTUAL, armsInterventionsModule interventions name: GR2001, interventions name: Placebo, interventions name: HTIG, interventions name: Tetanus Toxoid, outcomesModule primaryOutcomes measure: Incidence of AEs(Phase I), primaryOutcomes measure: Tetanus-antibody titer(Phase II), secondaryOutcomes measure: Tetanus-antibody titer(Phase I/II), secondaryOutcomes measure: Incidence of ADA(Phase I/II), secondaryOutcomes measure: Incidence of AEs(Phase II), secondaryOutcomes measure: Peak plasma concentration(Cmax), secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Time of maximum plasma concentration (Tmax), secondaryOutcomes measure: Terminal half-life (T1/2), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (Vd/F), secondaryOutcomes measure: The elimination rate constant (Kel), secondaryOutcomes measure: Mean Residence Time (MRT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Huashan Hospital affiliated of Fudan University, city: Shanghai, state: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False