{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["16(1)"],"submitter":["Yang Y"],"pubmed_abstract":["Background
SHR-1707 is a novel humanized anti-Aβ IgG1 monoclonal antibody that binds to Aβ fibrils and monomers to block the formation of Aβ plaques or to promote the microglial phagocytosis of Aβ. Preclinical studies showed that SHR-1707 reduced brain Aβ deposition in 5xFAD transgenic mice. Herein, we conducted two phase 1 studies to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous dose of SHR-1707 in healthy adult subjects.Methods
Two randomized, double-blind, single-ascending-dose, phase 1 studies were conducted in China (Study CHN) and Australia (Study AUS). Study CHN consisted of 2 parts. In Part 1, eligible healthy young adults (18-45 years) were sequentially randomized 8:2 to receive SHR-1707 (five cohorts: 2,"],"journal":["Alzheimer's research & therapy"],"pagination":["218"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11465679"],"repository":["biostudies-literature"],"pubmed_title":["Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies."],"pmcid":["PMC11465679"],"pubmed_authors":["Wu J","Shen K","Qiu H","Fan Y","Hu W","Zhou R","Williams J","Cui X","Fei Y","Zhang Q","Ye Z","Li N","Shakib S","Liu Y","Yang Y","Dong F","Wang Q","Zhang X","Qin H","Ma J","Feng S","Xu Y"],"additional_accession":[]},"is_claimable":false,"name":"Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies.","description":"Background
SHR-1707 is a novel humanized anti-Aβ IgG1 monoclonal antibody that binds to Aβ fibrils and monomers to block the formation of Aβ plaques or to promote the microglial phagocytosis of Aβ. Preclinical studies showed that SHR-1707 reduced brain Aβ deposition in 5xFAD transgenic mice. Herein, we conducted two phase 1 studies to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous dose of SHR-1707 in healthy adult subjects.Methods
Two randomized, double-blind, single-ascending-dose, phase 1 studies were conducted in China (Study CHN) and Australia (Study AUS). Study CHN consisted of 2 parts. In Part 1, eligible healthy young adults (18-45 years) were sequentially randomized 8:2 to receive SHR-1707 (five cohorts: 2,","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Oct","modification":"2026-05-29T11:17:45.145Z","creation":"2025-04-04T13:54:08.052Z"},"accession":"S-EPMC11465679","cross_references":{"pubmed":["39390616"],"doi":["10.1186/s13195-024-01584-8"]}}