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An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

NCT00960362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-01-30

No results posted yet for this study

Summary

This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).

Conditions

Interventions

DRUG

AGS-009

Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)

DRUG

placebo

Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.

Sponsors & Collaborators

  • Argos Therapeutics

    lead INDUSTRY

Principal Investigators

  • Fred Miesowicz, Ph.D. · Argos Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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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 NCT00960362 on ClinicalTrials.gov