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 2
2021
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2
Zhang Q, Zhou R, Yang J, Dou C, Gan T, Liu F, Hu B, Song D, Lu C, Hu W. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. Infectious Diseases And Therapy 2021, 11: 405-422. PMID: 34878625, PMCID: PMC8651971, DOI: 10.1007/s40121-021-00572-x.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsDrug-related treatment-emergent adverse eventsChinese healthy adultsSingle doseHealthy adultsElimination half-life valuesConclusionsA single doseDifferent dose cohortsPlacebo-controlled trialHuman neutralizing antibodiesYears of ageHuman clinical trialsSARS-CoV-2Monoclonal antibody distributionDose cohortsPlacebo-ControlledAdverse eventsDose proportionalityIntravenous infusionNeutralizing antibodiesBlood creatinineDosage groupsClinical trialsPlaceboPharmacokinetic profile