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

Progressive Multiple Sclerosis Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis

Status Completed

Clinical Trial 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.

Clinical Trial Description

The total study duration from screening for a patient can be approximately up to 8 weeks.

Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Progressive Multiple Sclerosis
• Sclerosis

• NCT number: NCT02282826
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Completion date: March 2016