drugset / Trial / NCT02977533

A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

NCT02977533

Phase 1 Completed 20 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in men and women with progressive multiple sclerosis. Secondary Objectives: To assess in men and women with progressive multiple sclerosis: * The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose. * The pharmacodynamic (PD) response to GZ402668 after a single SC dose.

Timeline

Start
2016-12-01
Primary completion
2018-05-16
Completion
2018-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject GATRALIMAB Monoclonal antibody 36 mg Subcutaneous
Subject GATRALIMAB Monoclonal antibody 48 mg Subcutaneous
Subject GATRALIMAB Monoclonal antibody 60 mg Subcutaneous
Background Acyclovir Small molecule Oral

Indications