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Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS

NCT01764737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-02-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with multiple sclerosis. The escalation part of the study will determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is found.

Conditions

Interventions

DRUG

VX15/2503

single dose intravenous administration

DRUG

Placebo

single dose intravenous administration

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Vaccinex Inc.

    lead INDUSTRY

Principal Investigators

  • John Leonard, PhD · Vaccinex Inc.

  • Keith R Edwards, MD, FAAD · MS Center of Northeastern NY/Empire Neurology

  • Christopher C LaGanke, MD · North Central Neurology Associates, PC

  • T H Rao, MD · The Neurological Institute, PA

  • Lawrence M Samkoff, MD · University of Rochester

  • Lael A Stone, MD · The Cleveland Clinic

  • Omar Khan, MD · Wayne State University - University Health Center

  • Sharon Lynch, MD · University of Kansas Medical Center

  • David H Mattson, MD · Indiana University Health Neuroscience Center

  • Timothy Vollmer, MD · University of Colorado Hospital, Anschutz Inpatient Pavilion

  • Pavle Repovic, MD · Swedish Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

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 NCT01764737 on ClinicalTrials.gov