A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Summary

Primary Objective: To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis. Secondary Objectives: To assess the following in men and women with progressive multiple sclerosis: * The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses. * The pharmacodynamics (PD) of GZ402668 after ascending single IV doses. * The PK parameters of GZ402668 after ascending single SC doses. * The PD of GZ402668 after ascending single SC doses.

Timeline

Start

2014-10

Primary completion

2016-03

Completion

2016-03

Publications

• Albach FN, Geier C, Keicher C, Posch MG, Schreiber SJ, Grutz G, Akyuz L, Luo X, Le-Halpere A, Truffinet P, Wagner F. Phase 1 Trials of Gatralimab, a Next-Generation Humanized Anti-CD52 Monoclonal Antibody, in Participants with Progressive Multiple Sclerosis. Neurol Ther. 2024 Dec;13(6):1607-1625. doi: 10.1007/s40120-024-00659-w. Epub 2024 Sep 9.

Drugs

Indications