2024
Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies
Yang Y, Qiu H, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Zhang Q, Ye Z, Ma J, Xu Y, Feng S, Fei Y, Li N, Cui X, Dong F, Wang Q, Shen K, Shakib S, Williams J, Hu W. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. Alzheimer's Research & Therapy 2024, 16: 218. PMID: 39390616, PMCID: PMC11465679, DOI: 10.1186/s13195-024-01584-8.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsPhase 1 studySingle-ascending-doseIntravenous doseHealthy adult subjectsDouble-blindElderly subjectsHealthy young adultsAdult subjectsTransient laboratory abnormalitiesPD profilesDose-proportional mannerSingle intravenous dosesYoung adultsDose-dependent increaseIgG1 monoclonal antibodyDose cohortsPlacebo groupLaboratory abnormalitiesPreclinical studiesAdverse eventsClinical developmentDose levelsNo ethnic differencesTransgenic mice
2023
Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR‐1707 in healthy adult subjects: two randomized, double‐blind, phase 1 studies
Hu W, Shakib S, Williams J, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Yang Y, Zhang Q, Ye Z, Qiu H, Ma J, Zhu M, Feng S, Fei Y, Li N, Cui X, Dong F, Wang T. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR‐1707 in healthy adult subjects: two randomized, double‐blind, phase 1 studies. Alzheimer's & Dementia 2023, 19 DOI: 10.1002/alz.074758.Peer-Reviewed Original ResearchPhase 1 studySingle intravenous doseHealthy young adultsPK/PD profilesHealthy adult subjectsIntravenous doseElderly subjectsYoung adultsDose levelsPD profilesAdult subjectsDose-proportional mannerPK/pharmacodynamicsFurther clinical developmentDose-dependent increaseSame dose levelIgG1 monoclonal antibodyPlacebo groupLaboratory abnormalitiesMicroglial phagocytosisAβ plaquesPreclinical studiesSHRClinical developmentAβ42 concentrations