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 miceA 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
2021
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
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