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
2021
A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects
Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects. Expert Opinion On Biological Therapy 2021, 22: 263-269. PMID: 34913787, DOI: 10.1080/14712598.2022.2019703.Peer-Reviewed Original ResearchMeSH KeywordsArea Under CurveBevacizumabBiosimilar PharmaceuticalsChinaDouble-Blind MethodHealthy VolunteersHumansMaleTherapeutic EquivalencyConceptsHealthy Chinese male subjectsChinese male subjectsStudy endpointBevacizumab biosimilarPK parametersMale subjectsGMRs of AUCParallel-group studyPrimary study endpointSecondary study endpointsMaximum serum concentrationLast quantifiable concentrationFurther clinical evaluationConcentration-time curveHealthy Chinese malesInhibitors of angiogenesisAnti-cancer therapyImmunogenicity profileComparable safetySimilar immunogenicitySerum concentrationsClinical evaluationBioequivalence marginTime zeroHealthy subjectsBioequivalence and Pharmacokinetic Evaluation of Two Oral Formulations of Regorafenib: An Open-Label, Randomised, Single-Dose, Two-Period, Two-Way Crossover Clinical Trial in Healthy Chinese Volunteers Under Fasting and Fed Conditions
Zhang Q, Wang Z, Wu J, Zhou Z, Zhou R, Hu W. Bioequivalence and Pharmacokinetic Evaluation of Two Oral Formulations of Regorafenib: An Open-Label, Randomised, Single-Dose, Two-Period, Two-Way Crossover Clinical Trial in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Design Development And Therapy 2021, 15: 3277-3288. PMID: 34349503, PMCID: PMC8328391, DOI: 10.2147/dddt.s323169.Peer-Reviewed Original ResearchConceptsHealthy Chinese volunteersSingle oral doseChinese volunteersFed conditionsOral doseSafety profileTwo-way crossover clinical trialSimilar favourable safety profileGeometric least-squares meansOral multi-kinase inhibitorPhase 1 trialCrossover clinical trialFavorable safety profileGood safety profileNon-compartmental methodsMulti-kinase inhibitorTwo-periodOpen labelAdverse eventsSingle doseClinical trialsPharmacokinetic evaluationOral formulationRegorafenibPharmacokinetic parameters