Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

Summary

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Timeline

Start

2014-06

Primary completion

2016-09

Completion

—

Outcome

Met primary endpoint

release “PRX002 was found to have an acceptable safety and tolerability profile in patients with Parkinson's disease, meeting the primary objective of this study.” prothena.com ↗

release “demonstrated that PRX002/RG7935 was found to have an acceptable safety and tolerability profile in patients with Parkinson's disease, meeting the primary objective of this study.” prothena.com ↗

Publications

• Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.
• Schenk DB, Koller M, Ness DK, Griffith SG, Grundman M, Zago W, Soto J, Atiee G, Ostrowitzki S, Kinney GG. First-in-human assessment of PRX002, an anti-alpha-synuclein monoclonal antibody, in healthy volunteers. Mov Disord. 2017 Feb;32(2):211-218. doi: 10.1002/mds.26878. Epub 2016 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prasinezumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Prasinezumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Prasinezumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Prasinezumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Prasinezumab	Monoclonal antibody	30 mg/kg	Intravenous
Subject	Prasinezumab	Monoclonal antibody	60 mg/kg	Intravenous

Indications