A randomized, single ascending dose study of intravenous BIIB092 in healthy participants.

ABSTRACT:

Introduction

Extracellular tau is hypothesized to mediate the onset and progression of tauopathies, including Alzheimer's disease, progressive supranuclear palsy, and a subset of frontotemporal lobar degenerations. A putative strategy for treating these disorders is to reduce extracellular tau levels using tau-directed immunotherapy. The results of the first-in-human study of BIIB092 (formerly BMS-986168/IPN007), a humanized monoclonal antibody that binds to N-terminal tau, are reported here. This randomized, double-blind, single ascending dose study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity profile of BIIB092 after a single intravenous infusion in healthy participants.

Methods

Sixty-five participants were randomized to receiv

SUBMITTER: Qureshi IA 

PROVIDER: S-EPMC6298197 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature