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Safety Study of GNbAC1 in Multiple Sclerosis Patients

NCT01639300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-02-08

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.

Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis.

GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.

Conditions

Interventions

BIOLOGICAL

GNbAC1

Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg

BIOLOGICAL

GNbAC1 placebo

Single dose intravenous (IV) GNbAC1 placebo

Sponsors & Collaborators

  • GeNeuro Innovation SAS

    lead INDUSTRY

Principal Investigators

  • Tobias Derfuss, MD · University Hospital, Basel, Switzerland

  • Patrice Lalive, MD · HUG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Switzerland

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 NCT01639300 on ClinicalTrials.gov