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An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

NCT01803867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-02-27

No results posted yet for this study

Summary

This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.

Conditions

Interventions

DRUG

rHIgM22

Administered via IV infusion

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Enrique Carrazana, MD · Acorda Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01803867 on ClinicalTrials.gov