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