NCT02282826

A First-in-human, 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 Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: intravenous
DRUG	placebo	Pharmaceutical form:solution Route of administration: intravenous
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: 2014-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-11-04
• Last updated: 2016-04-13

Locations

1 site across 1 country: Germany