2024
Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind Phase I study in healthy subjects
Sun C, Liu H, Ouyang Z, Ding J, Zhang Q, Ma H, Xu D, Zhang Q, Zhou R, Yang M, Hu W. Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind Phase I study in healthy subjects. Expert Opinion On Investigational Drugs 2024, 33: 533-542. PMID: 38662639, DOI: 10.1080/13543784.2024.2347302.Peer-Reviewed Original ResearchArea under the curveAscending-dose studyFood effect studyHealthy subjectsPlacebo-controlled phase I studySARS-CoV-2Increased approximately dose-proportionallyPlasma concentrationsTreatment-related adverse eventsApproximately dose-proportionallyPhase I studyHigh-fat mealBroad-spectrum antiviral drugsPreclinical activityDose proportionalityDouble-blindPlacebo-controlledReport safetyDose groupSafety profileStandard mealAdverse eventsSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Respiratory syndrome coronavirus 2Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clinical Pharmacokinetics 2024, 63: 293-302. PMID: 38198010, DOI: 10.1007/s40262-023-01330-7.Peer-Reviewed Original ResearchP2X3 receptor antagonistAdverse eventsReceptor antagonistHealthy subjectsChronic coughPlacebo-controlled phase 1 trialModerate adverse eventsMost adverse eventsTwice-daily dosingSelective P2X3 receptor antagonistPhase 1 studyPhase 1 trialUnexplained chronic coughSingle oral doseStudy phaseMedian tmaxPrimary endpointGood tolerabilityOral doseTherapeutic optionsResultsA totalDrug exposureMean t1/2Lower incidenceFood intake
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 ResearchConceptsHealthy 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 subjects