Phase 1 Studies of the Anti-Tau Monoclonal Antibody JNJ-63733657 in Healthy Participants and Participants with Alzheimer's Disease.

ABSTRACT:

Background

JNJ-63733657 (posdinemab) is a humanized IgG1/kappa monoclonal anti-phospho tau antibody that binds with high affinity to phosphorylated amino acid 217 (pT217) in the proline-rich domain. The parent molecule, PT3, was raised against Alzheimer's disease brain purified paired helical filament, and preclinical studies with the humanized version, JNJ-63733657, have demonstrated reductions in tau seeding. The results of the first-in-human clinical trial of JNJ-63733657 and a separate single ascending dose study in Japanese participants are presented.

Objectives

To evaluate the safety and tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of JNJ-63733657 after single and multiple intravenous dose administrations in healthy participants and participants

SUBMITTER: Galpern WR 

PROVIDER: S-EPMC11573813 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature