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Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis

NCT01585766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-10-29

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).

Conditions

  • Multiple Sclerosis, Relapsing Forms

Interventions

DRUG

MEDI-551 30 MG-IV

Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.

DRUG

MEDI-551 60 MG-SC

Participants received SC injection of 60 mg MEDI-551 on Day 1.

DRUG

PLACEBO-IV-SC

Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1

DRUG

MEDI-551 100 MG-IV

Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.

DRUG

MEDI-551 300 MG-SC

Participants received SC injection of 300 mg MEDI-551 on Day 1.

DRUG

MEDI-551 600 MG-IV

Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Armando Flor · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-24
Primary Completion
2015-01-02
Completion
2016-06-20
FDA Drug
Yes

Countries

  • United States
  • Poland
  • Spain
  • Ukraine

Study Locations

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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 NCT01585766 on ClinicalTrials.gov