Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial
Wu J, Zhou R, Zhang Q, Zhang Q, Qin H, Ye Z, Xu Y, Feng S, Shu C, Shen Y, Fan Y, Wang Q, Du Y, Hu W. Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial. Diabetes Obesity And Metabolism 2023, 26: 901-910. PMID: 38100147, DOI: 10.1111/dom.15383.Peer-Reviewed Original ResearchGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsSingle ascending doseMAD partsReceptor agonistGeometric mean tNovel glucagon-like peptide-1 receptor agonistFood effectHealthy participantsMultiple ascending dosePhase 1 trialType 2 diabetesGLP-1RAsPrimary endpointSingle doseDay 29Day 28Mean reductionClinical developmentMean TBody weightPharmacokineticsPlaceboTolerabilityEffect trialSafety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial
Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. American Journal Of Cardiovascular Drugs 2023, 23: 101-112. PMID: 36622539, DOI: 10.1007/s40256-022-00562-5.Peer-Reviewed Original ResearchConceptsHealthy Chinese volunteersMultiple ascending dosesChinese volunteersDose titrationAdverse eventsPharmacodynamic profileSequential cohortsDose-escalation phase I trialTarget international normalized ratioTreatment-related adverse eventsSerious adverse eventsPhase I trialInternational normalized ratioTarget rangeHealthy Chinese populationAscending dosesI trialNormalized ratioStable anticoagulationTecarfarinCohortChinese populationTolerabilityEarly withdrawalVolunteers