2024
A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects
Yao F, Wang C, Ding J, Zhang Q, Zheng L, Zhang Q, Yang T, Zhang X, Shan Y, Hou S, Wang H, Zhou R, Hu W. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects. Drug Design Development And Therapy 2024, 18: 3891-3901. PMID: 39224901, PMCID: PMC11368109, DOI: 10.2147/dddt.s470619.Peer-Reviewed Original ResearchConceptsHealthy Chinese male subjectsChinese male subjectsGeometric mean ratiosAnti-drug antibodiesDouble-blindMale subjectsRates of anti-drug antibodiesPK parametersNon-radiographic axial spondyloarthritisIncidence of TEAEsPhase I studyPrimary study endpointInterleukin (IL)-17AArea under the curveEnthesitis-related arthritisTreatment of psoriasisConfidence intervalsSafety profileSingle doseHidradenitis suppurativaSecukinumabStudy endpointAdverse eventsAxial spondyloarthritisImmunogenicity analysis
2023
Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects
Zhang Q, Sun C, Wu J, Wu J, Zhang X, Liu Y, Dou C, Qin H, Zhang Q, Zhou R, Hu W. Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects. Expert Opinion On Biological Therapy 2023, 23: 727-735. PMID: 36880118, DOI: 10.1080/14712598.2023.2189009.Peer-Reviewed Original ResearchConceptsHealthy Chinese male subjectsChinese male subjectsGeometric mean ratiosMale subjectsImmunogenicity profilePK parametersGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsChinese Clinical Trial RegistryCardiovascular adverse eventsParallel-group studyPrimary study endpointClinical Trials RegistryMaximum serum concentrationLast quantifiable concentrationBiosimilar candidateConfidence intervalsConcentration-time curvePK similarityAdverse eventsGlycemic controlStudy endpointTrials RegistryImmunogenicity dataComparable safety