biostudies-literatureUnknown12(8)Nery FC<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 The journal of prevention of Alzheimer's disease100302https://www.ebi.ac.uk/biostudies/studies/S-EPMC12413702biostudies-literatureResults of the first-in-human, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.PMC12413702Stenkrona PNery FCHalldin CBullain SLanden JArnold HMYachnin JSingh DHirschhorn BWilkes DVarrone AMoren AFJones LXie JCuriale GWu SHering HBolin MKaliszczak MYesilalan EGallagher DSuttle BNag SfalseResults of the first-in-human, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.<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 2025-01-01T00:00:00Z2025 Sep2026-06-02T22:33:31.433Z2026-05-28T03:06:00.195ZS-EPMC124137024069567710.1016/j.tjpad.2025.100302