{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12(8)"],"submitter":["Nery FC"],"pubmed_abstract":["<h4>Background</h4>Preclinical studies have demonstrated that inhibition of the O-linked β-N-acetylglucosaminidase enzyme increases tau O-linked β-N-acetylglucosaminylation and may attenuate tau pathology in Alzheimer's disease.<h4>Objectives</h4>To examine the safety, tolerability, pharmacokinetics, and target occupancy of single- and multiple-ascending oral doses of the small-molecule O-linked β-N-acetylglucosaminidase inhibitor, BIIB113.<h4>Design</h4>Study 276HV101 was a first-in-human, multicenter, Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose trial.<h4>Setting</h4>72 participants were enrolled from February 2022 through July 2023.<h4>Participants</h4>Adult healthy female and infertile/vasectomized male participants.<h4>Intervention</h4>In "],"journal":["The journal of prevention of Alzheimer's disease"],"pagination":["100302"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12413702"],"repository":["biostudies-literature"],"pubmed_title":["Results of the first-in-human, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers."],"pmcid":["PMC12413702"],"pubmed_authors":["Stenkrona P","Nery FC","Halldin C","Bullain S","Landen J","Arnold HM","Yachnin J","Singh D","Hirschhorn B","Wilkes D","Varrone A","Moren AF","Jones L","Xie J","Curiale G","Wu S","Hering H","Bolin M","Kaliszczak M","Yesilalan E","Gallagher D","Suttle B","Nag S"],"additional_accession":[]},"is_claimable":false,"name":"Results of the first-in-human, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.","description":"<h4>Background</h4>Preclinical studies have demonstrated that inhibition of the O-linked β-N-acetylglucosaminidase enzyme increases tau O-linked β-N-acetylglucosaminylation and may attenuate tau pathology in Alzheimer's disease.<h4>Objectives</h4>To examine the safety, tolerability, pharmacokinetics, and target occupancy of single- and multiple-ascending oral doses of the small-molecule O-linked β-N-acetylglucosaminidase inhibitor, BIIB113.<h4>Design</h4>Study 276HV101 was a first-in-human, multicenter, Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose trial.<h4>Setting</h4>72 participants were enrolled from February 2022 through July 2023.<h4>Participants</h4>Adult healthy female and infertile/vasectomized male participants.<h4>Intervention</h4>In ","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Sep","modification":"2026-06-02T22:33:31.433Z","creation":"2026-05-28T03:06:00.195Z"},"accession":"S-EPMC12413702","cross_references":{"pubmed":["40695677"],"doi":["10.1016/j.tjpad.2025.100302"]}}