A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects
Wang Y, Cheng Y, Guo Y, Fan Y, Zhou R, Zhang Q, Xu Y, Feng S, Shen K, Hu W. A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. European Journal Of Drug Metabolism And Pharmacokinetics 2025, 50: 265-272. PMID: 40252193, DOI: 10.1007/s13318-025-00944-5.Peer-Reviewed Original ResearchConceptsProprotein convertase subtilisin/kexin type 9Healthy Chinese subjectsPhase I studySubcutaneous injectionChinese subjectsAdverse eventsRatios of maximum serum concentrationRelative bioavailabilitySerum concentrationsTreatment-emergent adverse eventsLow-density lipoprotein cholesterol levelsIncidence of antidrug antibodiesGeometric mean ratiosHuman monoclonal antibodyMaximum serum concentrationLipoprotein cholesterol levelsSite groupsSingle subcutaneous injectionsUpper armBioavailabilityOpen-labelAntidrug antibodiesAUC0-lastDays postdoseLipid variables
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