NCT02977533

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

A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	GZ402668	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Acyclovir	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-05-16
• Completion: 2018-05-16
• First posted: 2016-11-30
• Last updated: 2022-04-25

Locations

1 site across 1 country: Germany