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

NCT02282826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-04-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282826 on ClinicalTrials.gov